All FDA drug approvals
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FDA drug approvals — brands starting with P
393 FDA applications with an approved original submission carry a brand starting with P, the earliest approved in 1942 and the most recent in 2026. FDA marks 197 of them discontinued, every product under the application. From the Drugs@FDA export of 2026-09-03.
| Brand | Ingredient | Approved | Sponsor | Application |
|---|---|---|---|---|
| PACLITAXEL | paclitaxel | AM REGENT | NDA211875 | |
| PACLITAXEL | paclitaxel | TEVA PHARMS INC | NDA216338 | |
| PADCEV | enfortumab vedotin-ejfv | ASTELLAS | BLA761137 | |
| PAGITANE | cycrimine hydrochloride | LILLY | NDA008951 | |
| PALLADONE | hydromorphone hydrochloride | PURDUE PHARMA LP | NDA021044 | |
| PALONOSETRON HYDROCHLORIDE | palonosetron hydrochloride | HIKMA | NDA207963 | |
| PALONOSETRON HYDROCHLORIDE | palonosetron hydrochloride | FRESENIUS KABI USA | NDA208109 | |
| PALSONIFY | paltusotine hydrochloride | CRINETICS | NDA219070 | |
| PALYNZIQ | pegvaliase-pqpz | BIOMARIN PHARM | BLA761079 | |
| PAMELOR | nortriptyline hydrochloride | SPECGX LLC | NDA018012 | |
| PAMELOR | nortriptyline hydrochloride | SPECGX LLC | NDA018013 | |
| PAMIDRONATE DISODIUM | pamidronate disodium | HIKMA | NDA021113 | |
| PAMINE FORTE | methscopolamine bromide | FOUGERA | NDA008848 | |
| PANCREAZE | pancrelipase (amylase, lipase, protease) | VIVUS INC | BLA022523 | |
| PANDEL | hydrocortisone probutate | ANI PHARMS | NDA020453 | |
| PANRETIN | alitretinoin | ADVANZ PHARMA | NDA020886 | |
| PANTOPRAZOLE SODIUM | pantoprazole sodium | HIKMA | NDA209463 | |
| PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE | pantoprazole sodium | BAXTER HLTHCARE CORP | NDA217512 | |
| PANWARFIN | warfarin sodium | ABBOTT | NDA017020 | |
| PARADIONE | paramethadione | ABBVIE | NDA006800 | |
| PARAFON FORTE DSC | chlorzoxazone | JANSSEN R AND D | NDA011529 | |
| PARAGARD T 380A | copper | COOPERSURGICAL | NDA018680 | |
| PARAPLATIN | carboplatin | CORDEN PHARMA | NDA019880 | |
| PARAPLATIN | carboplatin | CORDENPHARMA | NDA020452 | |
| PAREDRINE | hydroxyamphetamine hydrobromide | PHARMICS | NDA000004 | |
| PAREMYD | hydroxyamphetamine hydrobromide, tropicamide | EPIC PHARMA LLC | NDA019261 | |
| PARICALCITOL | paricalcitol | HOSPIRA | NDA201657 | |
| PARICALCITOL | paricalcitol | HIKMA PHARMS | NDA205917 | |
| PARICALCITOL | paricalcitol | ACCORD HLTHCARE | NDA207174 | |
| PARLODEL | bromocriptine mesylate | ESJAY PHARMA | NDA017962 | |
| PARNATE | tranylcypromine sulfate | ADVANZ PHARMA | NDA012342 | |
| PARSABIV | etelcalcetide | KAI PHARMS INC | NDA208325 | |
| PASATRU | garetosmab-grts | REGENERON PHARMACEUTICALS, INC | BLA761508 | |
| PASKALIUM | potassium aminosalicylate | GLENWOOD | NDA009395 | |
| PATADAY ONCE DAILY RELIEF | olopatadine hydrochloride | ALCON LABS INC | NDA021545 | |
| PATADAY ONCE DAILY RELIEF | olopatadine hydrochloride | ALCON LABS INC | NDA206276 | |
| PATADAY TWICE DAILY RELIEF | olopatadine hydrochloride | ALCON LABS INC | NDA020688 | |
| PATANASE | olopatadine hydrochloride | NOVARTIS | NDA021861 | |
| PATHILON | tridihexethyl chloride | LEDERLE | NDA009489 | |
| PATHOCIL | dicloxacillin sodium | WYETH AYERST | NDA050011 | |
| PATHOCIL | dicloxacillin sodium | WYETH AYERST | NDA050092 | |
| PAVBLU | aflibercept-ayyh | AMGEN INC | BLA761298 | |
| PAVULON | pancuronium bromide | ORGANON USA INC | NDA017015 | |
| PAXIL | paroxetine hydrochloride | APOTEX | NDA020031 | |
| PAXIL | paroxetine hydrochloride | APOTEX | NDA020710 | |
| PAXIL | paroxetine hydrochloride | APOTEX | NDA020885 | |
| PAXIL CR | paroxetine hydrochloride | APOTEX | NDA020936 | |
| PAXIPAM | halazepam | SCHERING | NDA017736 | |
| PAXLOVID (COPACKAGED) | nirmatrelvir, ritonavir | PFIZER | NDA217188 | |
| PBZ | tripelennamine citrate, tripelennamine hydrochloride | NOVARTIS | NDA005914 | |
| PBZ-SR | tripelennamine hydrochloride | NOVARTIS | NDA010533 | |
| PCE | erythromycin | AZURITY | NDA050611 | |
| PEDIAPRED | prednisolone sodium phosphate | PAI HOLDINGS | NDA019157 | |
| PEDIAZOLE | erythromycin ethylsuccinate, sulfisoxazole acetyl | ROSS LABS | NDA050529 | |
| PEDMARK | sodium thiosulfate | FENNEC PHARMS INC | NDA212937 | |
| PEGANONE | ethotoin | RECORDATI RARE | NDA010841 | |
| PEGASYS | peginterferon alfa-2a | Pharmaand GmbH | BLA103964 | |
| PEGINTRON | peginterferon alfa-2b | SCHERING | BLA103949 | |
| PEMAZYRE | pemigatinib | INCYTE CORP | NDA213736 | |
| PEMETREXED | pemetrexed | ACTAVIS | NDA208419 | |
| PEMETREXED | pemetrexed disodium | SHILPA | NDA215179 | |
| PEMETREXED DISODIUM | pemetrexed disodium | HOSPIRA | NDA214218 | |
| PEMETREXED DISODIUM | pemetrexed disodium | ACCORD HLTHCARE | NDA214408 | |
| PEMETREXED DISODIUM | pemetrexed disodium | SANDOZ | NDA214657 | |
| PEMETREXED DITROMETHAMINE | pemetrexed ditromethamine | HOSPIRA | NDA208746 | |
| PEMFEXY | pemetrexed | EAGLE PHARMS | NDA209472 | |
| PENBRITIN-S | ampicillin sodium | WYETH AYERST | NDA050072 | |
| PENETREX | enoxacin | SANOFI AVENTIS US | NDA019616 | |
| PENICILLIN G POTASSIUM IN PLASTIC CONTAINER | penicillin g potassium | BAXTER HLTHCARE | NDA050638 | |
| PENLAC | ciclopirox | VALEANT BERMUDA | NDA021022 | |
| PENNSAID | diclofenac sodium | NUVO PHARMS INC | NDA020947 | |
| PENNSAID | diclofenac sodium | HORIZON | NDA204623 | |
| PENPULIMAB-KCQX | penpulimab-kcqx | AKESO BIOPHARMA | BLA761258 | |
| PENTAM | pentamidine isethionate | FRESENIUS KABI USA | NDA019264 | |
| PENTASA | mesalamine | TAKEDA PHARMS USA | NDA020049 | |
| PENTETATE CALCIUM TRISODIUM | pentetate calcium trisodium | HAMELN | NDA021749 | |
| PENTETATE ZINC TRISODIUM | pentetate zinc trisodium | HAMELN PHARMA PLUS | NDA021751 | |
| PENTHRANE | methoxyflurane | ABBOTT | NDA013056 | |
| PENTOTHAL | thiopental sodium | ABBOTT | NDA011679 | |
| PEPCID | famotidine | BAUSCH | NDA019462 | |
| PEPCID | famotidine | SALIX PHARMS | NDA019527 | |
| PEPCID AC | famotidine | KENVUE BRANDS | NDA020325 | |
| PEPCID AC | famotidine | KENVUE BRANDS | NDA020801 | |
| PEPCID AC | famotidine | J AND J CONSUMER INC | NDA020902 | |
| PEPCID COMPLETE | calcium carbonate, famotidine, magnesium hydroxide | KENVUE BRANDS | NDA020958 | |
| PEPCID PRESERVATIVE FREE | famotidine | MERCK | NDA019510 | |
| PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER | famotidine | MERCK SHARP DOHME | NDA020249 | |
| PEPCID RPD | famotidine | MERCK | NDA020752 | |
| PEPTAVLON | pentagastrin | WYETH AYERST | NDA017048 | |
| PERCHLORACAP | potassium perchlorate | MALLINCKRODT | NDA017551 | |
| PERCODAN | aspirin, oxycodone hydrochloride, oxycodone terephthalate | ENDO OPERATIONS | NDA007337 | |
| PERCORTEN | desoxycorticosterone acetate | NOVARTIS | NDA005151 | |
| PERFOROMIST | formoterol fumarate | VIATRIS SPECIALTY | NDA022007 | |
| PERGONAL | menotropins (fsh, lh) | SERONO | BLA017646 | |
| PERIACTIN | cyproheptadine hydrochloride | MERCK | NDA012649 | |
| PERIACTIN | cyproheptadine hydrochloride | MERCK | NDA013220 | |
| PERIDEX | chlorhexidine gluconate | SOLVENTUM | NDA019028 | |
| PERIOCHIP | chlorhexidine gluconate | DEXCEL PHARMA | NDA020774 | |
| PERIOSTAT | doxycycline hyclate | COLLAGENEX | NDA050744 | |
| PERIOSTAT | doxycycline hyclate | GALDERMA LABS LP | NDA050783 | |
| PERJETA | pertuzumab | GENENTECH | BLA125409 | |
| PERMAPEN | penicillin g benzathine | CASPER PHARMA LLC | NDA060014 | |
| PERMAX | pergolide mesylate | VALEANT PHARM INTL | NDA019385 | |
| PERMITIL | fluphenazine hydrochloride | SCHERING | NDA012034 | |
| PERMITIL | fluphenazine hydrochloride | SCHERING | NDA012419 | |
| PERMITIL | fluphenazine hydrochloride | SCHERING | NDA016008 | |
| PERSANTINE | dipyridamole | BOEHRINGER INGELHEIM | NDA012836 | |
| PERSERIS KIT | risperidone | INDIVIOR | NDA210655 | |
| PERTOFRANE | desipramine hydrochloride | SANOFI AVENTIS US | NDA013621 | |
| PERTZYE | pancrelipase (amylase, lipase, protease) | DIGESTIVE CARE INC | BLA022175 | |
| PEXEVA | paroxetine mesylate | SEBELA IRELAND LTD | NDA021299 | |
| PHARMASEAL SCRUB CARE | chlorhexidine gluconate | CAREFUSION 2200 | NDA019793 | |
| PHEBURANE | sodium phenylbutyrate | MEDUNIK | NDA216513 | |
| PHENDIMETRAZINE TARTRATE | phendimetrazine tartrate | ACERTIS PHARMS | NDA018074 | |
| PHENERGAN | promethazine hydrochloride | DELCOR ASSET CORP | NDA007935 | |
| PHENERGAN | promethazine hydrochloride | WYETH AYERST | NDA008857 | |
| PHENERGAN | promethazine hydrochloride | PHARMOBEDIENT | NDA010926 | |
| PHENERGAN | promethazine hydrochloride | PHARMOBEDIENT | NDA011689 | |
| PHENERGAN VC | phenylephrine hydrochloride, promethazine hydrochloride | ANI PHARMS | NDA008604 | |
| PHENERGAN W/ CODEINE | codeine phosphate, promethazine hydrochloride, phenylephrine hydrochloride | ANI PHARMS | NDA008306 | |
| PHENURONE | phenacemide | ABBVIE | NDA007707 | |
| PHENYLEPHRINE HYDROCHLORIDE | phenylephrine hydrochloride | PARAGON BIOTECK | NDA203510 | |
| PHENYLEPHRINE HYDROCHLORIDE | phenylephrine hydrochloride | ALCON | NDA207926 | |
| PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE | phenylephrine hydrochloride | DR REDDYS LABS SA | NDA216830 | |
| PHESGO | pertuzumab, trastuzumab, and hyaluronidase-zzxf | GENENTECH INC | BLA761170 | |
| PHEXX | citric acid, lactic acid, potassium bitartrate | EVOFEM INC | NDA208352 | |
| PHISO-SCRUB | hexachlorophene | SANOFI AVENTIS US | NDA017446 | |
| PHISOHEX | hexachlorophene | SANOFI AVENTIS US | NDA006882 | |
| PHOSLO | calcium acetate | FRESENIUS MEDCL CARE | NDA019976 | |
| PHOSLO GELCAPS | calcium acetate | FRESENIUS MEDCL CARE | NDA021160 | |
| PHOSLYRA | calcium acetate | FRESENIUS MEDCL CARE | NDA022581 | |
| PHOSPHOCOL P32 | chromic phosphate p-32 | CURIUM | NDA017084 | |
| PHOSPHOLINE IODIDE | echothiophate iodide | FERA PHARMS LLC | NDA011963 | |
| PHOSPHOTEC | technetium tc-99m pyrophosphate kit | BRACCO | NDA017680 | |
| PHOSPHOTOPE | sodium phosphate p-32 | BRACCO | NDA010927 | |
| PHOTOFRIN | porfimer sodium | PINNACLE BIOLGS | NDA020451 | |
| PHOTOFRIN | porfimer sodium | AXCAN SCANDIPHARM | NDA021525 | |
| PHOTREXA VISCOUS IN DEXTRAN 20% | riboflavin 5'-phosphate, riboflavin 5'-phosphate sodium | GLAUKOS | NDA203324 | |
| PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER | calcium chloride, magnesium chloride, potassium chloride, sodium bicarbonate, sodium chloride, sodium phosphate | VANTIVE US HLTHCARE | NDA207026 | |
| PHYRAGO | dasatinib | HANDA THERAP | NDA216099 | |
| PHYSIOLYTE IN PLASTIC CONTAINER | magnesium chloride, potassium chloride, sodium acetate, sodium chloride, sodium gluconate | B BRAUN | NDA019024 | |
| PHYSIOSOL IN PLASTIC CONTAINER | magnesium chloride, potassium chloride, sodium acetate, sodium chloride, sodium gluconate | OTSUKA ICU MEDCL | NDA017637 | |
| PHYSIOSOL PH 7.4 IN PLASTIC CONTAINER | magnesium chloride, potassium chloride, sodium acetate, sodium chloride, sodium gluconate | HOSPIRA INC | NDA018406 | |
| PIASKY | crovalimab-akkz | GENENTECH INC | BLA761388 | |
| PICATO | ingenol mebutate | LEO LABS | NDA202833 | |
| PIFELTRO | doravirine | MSD MERCK CO | NDA210806 | |
| PILOPINE HS | pilocarpine hydrochloride | ALCON | NDA018796 | |
| PINDAC | pinacidil | LEO PHARM | NDA019456 | |
| PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINER | piperacillin sodium, tazobactam sodium | B BRAUN MEDICAL | NDA206056 | |
| PIPRACIL | piperacillin sodium | WYETH PHARMS INC | NDA050545 | |
| PIQRAY | alpelisib | NOVARTIS | NDA212526 | |
| PITOCIN | oxytocin | PH HEALTH | NDA018261 | |
| PIVYA | pivmecillinam hydrochloride | ALEMBIC THERAP | NDA216483 | |
| PIZENSY | lactitol | BRAINTREE LABS | NDA211281 | |
| PLACIDYL | ethchlorvynol | ABBVIE | NDA010021 | |
| PLAN B | levonorgestrel | FDN CONSUMER | NDA021045 | |
| PLAN B ONE-STEP | levonorgestrel | FDN CONSUMER | NDA021998 | |
| PLAQUENIL | hydroxychloroquine sulfate | ADVANZ PHARMA | NDA009768 | |
| PLASMA-LYTE 148 AND DEXTROSE 5% IN PLASTIC CONTAINER | dextrose, magnesium chloride, potassium chloride, sodium acetate, sodium chloride, sodium gluconate | BAXTER HLTHCARE | NDA017451 | |
| PLASMA-LYTE 56 AND DEXTROSE 5% IN PLASTIC CONTAINER | dextrose, magnesium acetate tetrahydrate, potassium acetate, sodium chloride | BAXTER HLTHCARE | NDA017385 | |
| PLASMA-LYTE 56 IN PLASTIC CONTAINER | magnesium acetate tetrahydrate, potassium acetate, sodium chloride | BAXTER HLTHCARE | NDA019047 | |
| PLASMA-LYTE A IN PLASTIC CONTAINER | magnesium chloride, potassium chloride, sodium acetate, sodium chloride, sodium gluconate | BAXTER HLTHCARE | NDA017378 | |
| PLASMA-LYTE M AND DEXTROSE 5% IN PLASTIC CONTAINER | calcium chloride, dextrose, magnesium chloride, potassium chloride, sodium acetate, sodium chloride, sodium lactate | BAXTER HLTHCARE | NDA017390 | |
| PLASMA-LYTE R IN PLASTIC CONTAINER | calcium chloride, magnesium chloride, potassium chloride, sodium acetate, sodium chloride, sodium lactate | BAXTER HLTHCARE | NDA017438 | |
| PLATINOL-AQ | cisplatin | HQ SPCLT PHARMA | NDA018057 | |
| PLAVIX | clopidogrel bisulfate | SANOFI AVENTIS US | NDA020839 | |
| PLEGISOL IN PLASTIC CONTAINER | calcium chloride, magnesium chloride, potassium chloride, sodium chloride | HOSPIRA | NDA018608 | |
| PLEGRIDY | peginterferon beta-1a | BIOGEN IDEC INC | BLA125499 | |
| PLENAXIS | abarelix | SPECIALITY EUROPEAN | NDA021320 | |
| PLENDIL | felodipine | ASTRAZENECA | NDA019834 | |
| PLENVU | ascorbic acid, polyethylene glycol 3350, potassium chloride, sodium ascorbate, sodium chloride, sodium sulfate | NORGINE | NDA209381 | |
| PLETAL | cilostazol | OTSUKA | NDA020863 | |
| PLIAGLIS | lidocaine, tetracaine | CRESCITA THERAP | NDA021717 | |
| PLUVICTO | lutetium lu-177 vipivotide tetraxetan | NOVARTIS | NDA215833 | |
| PMB 200 | estrogens, conjugated, meprobamate | WYETH AYERST | NDA010971 | |
| POHERDY | pertuzumab-dpzb | SHANGHAI HENLIUS BIOTECH | BLA761450 | |
| POKONZA | potassium chloride | GENUS LIFESCIENCES | NDA206814 | |
| POKONZA | potassium chloride | GENUS | NDA208019 | |
| POLIVY | polatuzumab vedotin-piiq | GENENTECH | BLA761121 | |
| POLY-PRED | neomycin sulfate, polymyxin b sulfate, prednisolone acetate | ALLERGAN | NDA050081 | |
| POLYTRIM | polymyxin b sulfate, trimethoprim sulfate | ALLERGAN | NDA050567 | |
| POMALYST | pomalidomide | BRISTOL | NDA204026 | |
| POMBILITI | cipaglucosidase alfa-atga | AMICUS THERAP US | BLA761204 | |
| PONLIMSI | denosumab-adet | TEVA PHARMACEUTICALS, INC. | BLA761385 | |
| PONSTEL | mefenamic acid | AVION PHARMS | NDA015034 | |
| PONVORY | ponesimod | VANDA PHARMS INC | NDA213498 | |
| PORCINE SECRETIN | porcine secretin | CHIRHOCLIN | NDA021209 | |
| PORTRAZZA | necitumumab | ELI LILLY CO | BLA125547 | |
| POSFREA | palonosetron hydrochloride | AVYXA HOLDINGS | NDA203050 | |
| POSIMIR | bupivacaine | INNOCOLL | NDA204803 | |
| POSLUMA | flotufolastat f-18 gallium | BLUE EARTH | NDA216023 | |
| POTASSIUM ACETATE | potassium acetate | HOSPIRA | NDA018896 | |
| POTASSIUM CHLORIDE | potassium chloride | SCHERING | NDA019439 | |
| POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | dextrose, potassium chloride, sodium chloride | B BRAUN | NDA019630 | |
| POTASSIUM CHLORIDE 0.22% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | potassium chloride, sodium chloride | B BRAUN | NDA019708 | |
| POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER | dextrose, potassium chloride | B BRAUN | NDA018744 | |
| POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER | dextrose, potassium chloride | B BRAUN | NDA019699 | |
| POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER | calcium chloride, dextrose, potassium chloride, sodium chloride, sodium lactate | OTSUKA ICU MEDCL | NDA019685 | |
| POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER | dextrose, potassium chloride, sodium chloride | OTSUKA ICU MEDCL | NDA018365 | |
| POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | dextrose, potassium chloride, sodium chloride | OTSUKA ICU MEDCL | NDA019691 | |
| POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER | potassium chloride | BAXTER HLTHCARE | NDA019904 | |
| POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER | potassium chloride | OTSUKA ICU MEDCL | NDA020161 | |
| POTASSIUM CHLORIDE 20MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | potassium chloride, sodium chloride | OTSUKA ICU MEDCL | NDA019686 | |
| POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | dextrose, potassium chloride, sodium chloride | BAXTER HLTHCARE | NDA018008 | |
| POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | dextrose, potassium chloride, sodium chloride | BAXTER HLTHCARE | NDA019308 | |
| POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER | dextrose, potassium chloride | OTSUKA ICU MEDCL | NDA018371 | |
| POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER | calcium chloride, dextrose, potassium chloride, sodium chloride, sodium lactate | BAXTER HLTHCARE | NDA019367 | |
| POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER | dextrose, potassium chloride, sodium chloride | ICU MEDICAL INC | NDA018876 | |
| POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | dextrose, potassium chloride, sodium chloride | OTSUKA ICU MEDCL | NDA018362 | |
| POTASSIUM CITRATE | potassium citrate | UT SW MEDCTR | NDA019647 | |
| POTASSIUM IODIDE | potassium iodide | ROXANE | NDA018551 | |
| POTASSIUM PHOSPHATES | potassium phosphate, dibasic, potassium phosphate, monobasic | CMP DEV LLC | NDA212121 | |
| POTASSIUM PHOSPHATES | potassium phosphate, dibasic, potassium phosphate, monobasic | FRESENIUS KABI USA | NDA212832 | |
| POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE | potassium phosphate, dibasic, potassium phosphate, monobasic | AMNEAL | NDA218343 | |
| POTELIGEO | mogamulizumab-kpkc | KYOWA KIRIN | BLA761051 | |
| POTIGA | ezogabine | GLAXOSMITHKLINE | NDA022345 | |
| POVIDONE IODINE | povidone-iodine | ALLEGIANCE HLTHCARE | NDA019522 | |
| PRADAXA | dabigatran etexilate mesylate | BOEHRINGER INGELHEIM | NDA022512 | |
| PRADAXA | dabigatran etexilate mesylate | BOEHRINGER INGELHEIM | NDA214358 | |
| PRALIDOXIME CHLORIDE (AUTOINJECTOR) | pralidoxime chloride | MERIDIAN MEDCL TECHN | NDA018986 | |
| PRALUENT | alirocumab | REGENERON PHARMACEUTICALS | BLA125559 | |
| PRANDIMET | metformin hydrochloride, repaglinide | NOVO NORDISK INC | NDA022386 | |
| PRANDIN | repaglinide | GEMINI LABS LLC | NDA020741 | |
| PRAVACHOL | pravastatin sodium | BRISTOL MYERS SQUIBB | NDA019898 | |
| PRAVIGARD PAC (COPACKAGED) | aspirin, pravastatin sodium | BRISTOL MYERS SQUIBB | NDA021387 | |
| PRAXBIND | idarucizumab | BOEHRINGER INGELHEIM | BLA761025 | |
| PRE-OP II | hexachlorophene | DAVIS AND GECK | NDA017433 | |
| PRE-PEN | benzylpenicilloyl polylysine | ALLERQUEST | BLA050114 | |
| PRECEDEX | dexmedetomidine hydrochloride | HOSPIRA | NDA021038 | |
| PRECEF | ceforanide | BRISTOL | NDA050554 | |
| PRECOSE | acarbose | BAYER HLTHCARE | NDA020482 | |
| PRED FORTE | prednisolone acetate | ABBVIE | NDA017011 | |
| PRED MILD | prednisolone acetate | ABBVIE | NDA017100 | |
| PRED-G | gentamicin sulfate, prednisolone acetate | ALLERGAN | NDA050586 | |
| PRED-G | gentamicin sulfate, prednisolone acetate | ALLERGAN | NDA050612 | |
| PREDNISONE | prednisone | ROXANE | NDA017109 | |
| PREFEST | estradiol, norgestimate | TEVA WOMENS | NDA021040 | |
| PREGNYL | gonadotropin, chorionic | ORGANON USA LLC | BLA017692 | |
| PRELAY | troglitazone | SANKYO | NDA020719 | |
| PREMARIN | estrogens, conjugated | WYETH PHARMS | NDA004782 | |
| PREMARIN | estrogens, conjugated | WYETH PHARMS | NDA010402 | |
| PREMARIN | estrogens, conjugated | WYETH PHARMS | NDA020216 | |
| PREMARIN | estrogens, conjugated | WYETH PHARMS INC | NDA021417 | |
| PREMPRO | estrogens, conjugated, medroxyprogesterone acetate | WYETH PHARMS | NDA020527 | |
| PREMPRO (PREMARIN;CYCRIN) | estrogens, conjugated, medroxyprogesterone acetate | WYETH PHARMS INC | NDA020303 | |
| PREMPRO/PREMPHASE | conjugated estrogens/medroxyprogesterone acetate | WYETH AYERST | NDA021396 | |
| PREPIDIL | dinoprostone | PFIZER | NDA019617 | |
| PREPOPIK | citric acid, magnesium oxide, sodium picosulfate | FERRING PHARMS INC | NDA202535 | |
| PRESAMINE | imipramine hydrochloride | SANOFI AVENTIS US | NDA011836 | |
| PRESTALIA | amlodipine besylate, perindopril arginine | ADHERA | NDA205003 | |
| PRETOMANID | pretomanid | MYLAN IRELAND LTD | NDA212862 | |
| PREVACID | lansoprazole | TAKEDA PHARMS USA | NDA020406 | |
| PREVACID | lansoprazole | TAKEDA PHARMS NA | NDA021281 | |
| PREVACID | lansoprazole | TAKEDA PHARMS USA | NDA021428 | |
| PREVACID 24 HR | lansoprazole | PERRIGO PHARMA INTL | NDA022327 | |
| PREVACID IV | lansoprazole | TAKEDA PHARMS NA | NDA021566 | |
| PREVACID NAPRAPAC 375 (COPACKAGED) | lansoprazole, naproxen | TAKEDA PHARMS NA | NDA021507 | |
| PREVANTICS SWABSTICK | chlorhexidine gluconate, isopropyl alcohol | PROF DSPLS | NDA021524 | |
| PREVDUO | glycopyrrolate, neostigmine methylsulfate | AZURITY | NDA216903 | |
| PREVEN EMERGENCY CONTRACEPTIVE KIT | ethinyl estradiol, levonorgestrel | TEVA BRANDED PHARM | NDA020946 | |
| PREVPAC (COPACKAGED) | amoxicillin, clarithromycin, lansoprazole | TAKEDA PHARMS USA | NDA050757 | |
| PREVYMIS | letermovir | MERCK SHARP DOHME | NDA209939 | |
| PREVYMIS | letermovir | MERCK SHARP DOHME | NDA209940 | |
| PREVYMIS | letermovir | MSD | NDA219104 | |
| PREXXARTAN | valsartan | CARMEL BIOSCIENCES | NDA209139 | |
| PREZCOBIX | cobicistat, darunavir ethanolate | JANSSEN PRODS | NDA205395 | |
| PREZCOBIX | darunavir and cobicistat, cobicistat, darunavir ethanolate | JANSSEN PRODS | NDA220092 | |
| PREZISTA | darunavir | JANSSEN PRODS | NDA021976 | |
| PREZISTA | darunavir | JANSSEN PRODS | NDA202895 | |
| PRIALT | ziconotide acetate | ESTEVE | NDA021060 | |
| PRIFTIN | rifapentine | SANOFI AVENTIS US | NDA021024 | |
| PRILOSEC | omeprazole | ASTRAZENECA | NDA019810 | |
| PRILOSEC | omeprazole magnesium | AZURITY | NDA022056 | |
| PRILOSEC OTC | omeprazole magnesium | ASTRAZENECA | NDA021229 | |
| PRIMACOR | milrinone lactate | SANOFI AVENTIS US | NDA019436 | |
| PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER | milrinone lactate | SANOFI AVENTIS US | NDA020343 | |
| PRIMAQUINE | primaquine phosphate | SANOFI AVENTIS US | NDA008316 | |
| PRIMATENE MIST | epinephrine | ARMSTRONG PHARMS | NDA205920 | |
| PRIMAXIN | cilastatin sodium, imipenem | MERCK | NDA050587 | |
| PRIMAXIN | cilastatin sodium, imipenem | MERCK | NDA050630 | |
| PRIMSOL | trimethoprim hydrochloride | PANGEA | NDA074374 | |
| PRIMSOL | trimethoprim hydrochloride | PANGEA | NDA074973 | |
| PRINIVIL | lisinopril | MERCK | NDA019558 | |
| PRINZIDE | hydrochlorothiazide, lisinopril | MERCK | NDA019778 | |
| PRISCOLINE | tolazoline hydrochloride | NOVARTIS | NDA006403 | |
| PRISMASOL B22GK 2/0 IN PLASTIC CONTAINER | calcium chloride, dextrose, lactic acid, magnesium chloride, potassium chloride, sodium bicarbonate, sodium chloride | VANTIVE US HLTHCARE | NDA021703 | |
| PRISTIQ | desvenlafaxine succinate | PF PRISM CV | NDA021992 | |
| PRO-BANTHINE | propantheline bromide | SHIRE | NDA008732 | |
| PROAIR HFA | albuterol sulfate | TEVA BRANDED PHARM | NDA021457 | |
| PROAIR RESPICLICK | albuterol sulfate | TEVA BRANDED PHARM | NDA205636 | |
| PROAMATINE | midodrine hydrochloride | TAKEDA PHARMS USA | NDA019815 | |
| PROBUPHINE | buprenorphine hydrochloride | REACX PHARMS | NDA204442 | |
| PROCALAMINE | amino acids, calcium acetate, glycerin, magnesium acetate, phosphoric acid, potassium chloride, sodium acetate, sodium chloride | B BRAUN | NDA018582 | |
| PROCANBID | procainamide hydrochloride | KING PHARMS | NDA020545 | |
| PROCARDIA | nifedipine | PFIZER | NDA018482 | |
| PROCARDIA XL | nifedipine | PFIZER | NDA019684 | |
| PROCYSBI | cysteamine bitartrate | HORIZON | NDA203389 | |
| PROCYSBI | cysteamine bitartrate | HORIZON | NDA213491 | |
| PROFENAL | suprofen | ALCON | NDA019387 | |
| PROFERDEX | iron dextran | NEW RIVER | NDA017807 | |
| PROGESTASERT | progesterone | ALZA | NDA017553 | |
| PROGESTERONE | progesterone | LILLY | NDA009238 | |
| PROGESTERONE | progesterone | ACTAVIS LABS UT INC | NDA017362 | |
| PROGLYCEM | diazoxide | TEVA BRANDED PHARM | NDA017425 | |
| PROGLYCEM | diazoxide | TEVA BRANDED PHARM | NDA017453 | |
| PROGRAF | tacrolimus | ASTELLAS | NDA050708 | |
| PROGRAF | tacrolimus | ASTELLAS | NDA050709 | |
| PROGRAF | tacrolimus | ASTELLAS | NDA210115 | |
| PROHANCE | gadoteridol | BRACCO | NDA020131 | |
| PROHANCE MULTIPACK | gadoteridol | BRACCO | NDA021489 | |
| PROKETAZINE | carphenazine maleate | WYETH AYERST | NDA014173 | |
| PROLENSA | bromfenac sodium | BAUSCH AND LOMB | NDA203168 | |
| PROLEUKIN | aldesleukin | CHIRON | BLA103293 | |
| PROLIA | denosumab | AMGEN | BLA125320 | |
| PROLIXIN | fluphenazine hydrochloride | APOTHECON | NDA011751 | |
| PROLIXIN | fluphenazine hydrochloride | APOTHECON | NDA012145 | |
| PROLIXIN DECANOATE | fluphenazine decanoate | BRISTOL MYERS SQUIBB | NDA016727 | |
| PROLIXIN ENANTHATE | fluphenazine enanthate | APOTHECON | NDA016110 | |
| PROLOPRIM | trimethoprim | MONARCH PHARMS | NDA017943 | |
| PROMACTA | eltrombopag olamine | NOVARTIS | NDA022291 | |
| PROMACTA KIT | eltrombopag olamine | NOVARTIS | NDA207027 | |
| PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | dextromethorphan hydrobromide, promethazine hydrochloride | ANI PHARMS | NDA011265 | |
| PROMETHAZINE HYDROCHLORIDE PLAIN | promethazine hydrochloride | ANI PHARMS | NDA008381 | |
| PROMETRIUM | progesterone | ACERTIS PHARMS | NDA019781 | |
| PROMETRIUM | progesterone | VIRTUS PHARMS | NDA020843 | |
| PRONESTYL | procainamide hydrochloride | APOTHECON | NDA007335 | |
| PRONESTYL | procainamide hydrochloride | APOTHECON | NDA017371 | |
| PROPECIA | finasteride | ORGANON | NDA020788 | |
| PROPINE | dipivefrin hydrochloride | ALLERGAN | NDA018239 | |
| PROPRANOLOL HYDROCHLORIDE | propranolol hydrochloride | BAXTER HLTHCARE CORP | NDA016419 | |
| PROPULSID | cisapride monohydrate | JANSSEN PHARMS | NDA020210 | |
| PROPULSID | cisapride monohydrate | JANSSEN PHARMS | NDA020398 | |
| PROPULSID QUICKSOLV | cisapride monohydrate | JANSSEN PHARMA | NDA020767 | |
| PROPYLTHIOURACIL | propylthiouracil | PH HEALTH | NDA006188 | |
| PROPYLTHIOURACIL | propylthiouracil | LILLY | NDA006213 | |
| PROQUIN XR | ciprofloxacin hydrochloride | DEPOMED INC | NDA021744 | |
| PROSCAR | finasteride | ORGANON | NDA020180 | |
| PROSOL 20% SULFITE FREE IN PLASTIC CONTAINER | amino acids | BAXTER HLTHCARE | NDA020849 | |
| PROSOM | estazolam | ABBOTT | NDA019080 | |
| PROSTASCINT | capromab pendetide | CYTOGEN | BLA103608 | |
| PROSTEP | nicotine | AVEVA | NDA019983 | |
| PROSTIN E2 | dinoprostone | PFIZER | NDA017810 | |
| PROSTIN VR PEDIATRIC | alprostadil | PFIZER | NDA018484 | |
| PROTAMINE SULFATE | protamine sulfate | LILLY | NDA006460 | |
| PROTONIX | pantoprazole sodium | WYETH PHARMS | NDA020987 | |
| PROTONIX | pantoprazole sodium | WYETH PHARMS | NDA022020 | |
| PROTONIX IV | pantoprazole sodium | WYETH PHARMS | NDA020988 | |
| PROTOPAM CHLORIDE | pralidoxime chloride | WYETH AYERST | NDA014122 | |
| PROTOPAM CHLORIDE | pralidoxime chloride | BAXTER HLTHCARE CORP | NDA014134 | |
| PROTOPAM CHLORIDE | pralidoxime chloride | BAXTER HLTHCARE CORP | NDA018799 | |
| PROTOPIC | tacrolimus | LEO PHARMA AS | NDA050777 | |
| PROTOSTAT | metronidazole | ORTHO MCNEIL PHARM | NDA018871 | |
| PROVAYBLUE | methylene blue | PROVEPHARM SAS | NDA204630 | |
| PROVENTIL | albuterol | SCHERING | NDA017559 | |
| PROVENTIL | albuterol sulfate | SCHERING | NDA017853 | |
| PROVENTIL | albuterol sulfate | SCHERING | NDA018062 | |
| PROVENTIL | albuterol sulfate | SCHERING | NDA019243 | |
| PROVENTIL | albuterol sulfate | SCHERING | NDA019383 | |
| PROVENTIL-HFA | albuterol sulfate | KINDEVA | NDA020503 | |
| PROVERA | medroxyprogesterone acetate | PFIZER | NDA011839 | |
| PROVIGIL | modafinil | NUVO PHARMS | NDA020717 | |
| PROVOCHOLINE | methacholine chloride | METHAPHARM | NDA019193 | |
| PROZAC | fluoxetine hydrochloride | LILLY | NDA020101 | |
| PROZAC | fluoxetine hydrochloride | LILLY | NDA020974 | |
| PROZAC WEEKLY | fluoxetine hydrochloride | LILLY | NDA021235 | |
| PSEUDO-12 | pseudoephedrine polistirex | UCB INC | NDA019401 | |
| PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE | chlorpheniramine maleate, pseudoephedrine hydrochloride | GRAHAM DM | NDA018843 | |
| PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE | chlorpheniramine maleate, pseudoephedrine hydrochloride | GRAHAM DM | NDA018844 | |
| PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE | chlorpheniramine maleate, pseudoephedrine hydrochloride | CENT PHARMS | NDA019428 | |
| PSORCON | diflorasone diacetate | PFIZER | NDA019260 | |
| PSORCON | diflorasone diacetate | TARO PHARMS NORTH | NDA020205 | |
| PSORCON E | diflorasone diacetate | PFIZER | NDA017994 | |
| PULMICORT | budesonide | ASTRAZENECA | NDA020441 | |
| PULMICORT FLEXHALER | budesonide | CHEPLAPHARM | NDA021949 | |
| PULMICORT RESPULES | budesonide | ASTRAZENECA | NDA020929 | |
| PULMOLITE | technetium tc-99m albumin aggregated kit | JUBILANT DRAXIMAGE | BLA017776 | |
| PULMOTECH MAA | technetium tc99m albumin aggregated | CIS BIO INTL | BLA210089 | |
| PULMOZYME | dornase alfa | GENENTECH | BLA103532 | |
| PUR-WASH | purified water | NIAGARA PHARMS | NDA022305 | |
| PURIFIED CORTROPHIN GEL | corticotropin | ANI PHARMS | NDA008975 | |
| PURINETHOL | mercaptopurine | STASON PHARMS | NDA009053 | |
| PURIXAN | mercaptopurine | NOVA LABS LTD | NDA205919 | |
| PYLARIFY | piflufolastat f-18 | PROGENICS PHARMS INC | NDA214793 | |
| PYLARIFY TRUVU | piflufolastat f-18 | APHELION | NDA220089 | |
| PYLERA | bismuth subcitrate potassium, metronidazole, tetracycline hydrochloride | LABS JUVISE | NDA050786 | |
| PYLORI-CHEK BREATH TEST | urea c-13 | DXS DEVICES | NDA020900 | |
| PYRIDOSTIGMINE BROMIDE | pyridostigmine bromide | US ARMY | NDA020414 | |
| PYRIDOSTIGMINE BROMIDE | pyridostigmine bromide | AMNEAL | NDA217604 | |
| PYROLITE | technetium tc-99m pyro/trimeta phosphates kit | PHARMALUCENCE | NDA017684 | |
| PYRUKYND | mitapivat sulfate | AGIOS PHARMS INC | NDA216196 | |
| PYTEST KIT | urea, c-14 | AVENT | NDA020617 | |
| PYZCHIVA | ustekinumab-ttwe | SAMSUNG BIOEPIS CO LTD | BLA761373 | |
| PYZCHIVA | ustekinumab-ttwe | SAMSUNG BIOEPIS CO LTD | BLA761425 |