All FDA drug approvals
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FDA drug approvals — brands starting with S
389 FDA applications with an approved original submission carry a brand starting with S, the earliest approved in 1939 and the most recent in 2026. FDA marks 170 of them discontinued, every product under the application. From the Drugs@FDA export of 2026-09-03.
| Brand | Ingredient | Approved | Sponsor | Application |
|---|---|---|---|---|
| SABRIL | vigabatrin | LUNDBECK PHARMS LLC | NDA020427 | |
| SABRIL | vigabatrin | LUNDBECK PHARMS LLC | NDA022006 | |
| SAFYRAL | drospirenone, ethinyl estradiol, levomefolate calcium | BAYER HLTHCARE | NDA022574 | |
| SAIZEN | somatropin | EMD SERONO | BLA019764 | |
| SALAGEN | pilocarpine hydrochloride | ADVANZ PHARMA | NDA020237 | |
| SALONPAS | menthol, methyl salicylate | HISAMITSU PHARM CO | NDA022029 | |
| SALPIX | acetrizoate sodium | ORTHO MCNEIL PHARM | NDA009008 | |
| SALURON | hydroflumethiazide | SHIRE LLC | NDA011949 | |
| SALUTENSIN | hydroflumethiazide, reserpine | SHIRE | NDA012359 | |
| SAMSCA | tolvaptan | OTSUKA | NDA022275 | |
| SANCTURA | trospium chloride | ALLERGAN | NDA021595 | |
| SANCTURA XR | trospium chloride | ALLERGAN | NDA022103 | |
| SANCUSO | granisetron | APOTEX | NDA022198 | |
| SANDIMMUNE | cyclosporine | NOVARTIS | NDA050573 | |
| SANDIMMUNE | cyclosporine | NOVARTIS | NDA050574 | |
| SANDIMMUNE | cyclosporine | NOVARTIS | NDA050625 | |
| SANDOSTATIN | octreotide acetate | NOVARTIS | NDA019667 | |
| SANDOSTATIN LAR | octreotide acetate | NOVARTIS | NDA021008 | |
| SANOREX | mazindol | NOVARTIS | NDA017247 | |
| SANSERT | methysergide maleate | NOVARTIS | NDA012516 | |
| SANTYL | collagenase | SMITH AND NEPHEW | BLA101995 | |
| SAPHNELO | anifrolumab-fnia | ASTRAZENECA AB | BLA761123 | |
| SAPHNELO | anifrolumab-fnia | ASTRAZENECA AB | BLA761451 | |
| SAPHRIS | asenapine maleate | ABBVIE | NDA022117 | |
| SARAFEM | fluoxetine hydrochloride | ELI LILLY AND CO | NDA018936 | |
| SARAFEM | fluoxetine hydrochloride | APIL | NDA021860 | |
| SARCLISA | isatuximab-irfc | SANOFI AVENTIS US | BLA761113 | |
| SARCLISA ESCENA | isatuximab-irfc | SANOFI-AVENTIS U.S. LLC | BLA761445 | |
| SAVAYSA | edoxaban tosylate | DAIICHI SANKYO INC | NDA206316 | |
| SAVELLA | milnacipran hydrochloride | ABBVIE | NDA022256 | |
| SAXENDA | liraglutide | NOVO | NDA206321 | |
| SCEMBLIX | asciminib hydrochloride | NOVARTIS | NDA215358 | |
| SCENESSE | afamelanotide | CLIVUNEL INC | NDA210797 | |
| SCLEROSOL | talc | SCIARRA LABS | NDA020587 | |
| SCRUBTEAM SURGICAL SPONGEBRUSH | hexachlorophene | 3M | NDA017413 | |
| SDAMLO | amlodipine besylate | BRILLIAN PHARMA | NDA219531 | |
| SEASONALE | ethinyl estradiol, levonorgestrel | TEVA BRANDED PHARM | NDA021544 | |
| SEASONIQUE | ethinyl estradiol, levonorgestrel | TEVA BRANDED PHARM | NDA021840 | |
| SECONAL SODIUM | secobarbital sodium | LILLY | NDA007392 | |
| SECREFLO | secretin synthetic porcine | CHIRHOCLIN | NDA021136 | |
| SECTRAL | acebutolol hydrochloride | PROMIUS PHARMA | NDA018917 | |
| SECUADO | asenapine | HISAMITSU | NDA212268 | |
| SEEBRI NEOHALER | glycopyrrolate | NOVARTIS | NDA207923 | |
| SEGLENTIS | celecoxib, tramadol hydrochloride | KOWA PHARMS | NDA213426 | |
| SEGLUROMET | ertugliflozin, metformin hydrochloride | MSD SUB MERCK | NDA209806 | |
| SEIZALAM | midazolam hydrochloride | MMT | NDA209566 | |
| SELARSDI | ustekinumab-aekn | ALVOTECH USA INC | BLA761343 | |
| SELEGILINE HYDROCHLORIDE | selegiline hydrochloride | QUAGEN | NDA019334 | |
| SELENIOUS ACID | selenious acid | AM REGENT | NDA209379 | |
| SELENOMETHIONINE SE 75 | selenomethionine se-75 | MALLINCKRODT | NDA017098 | |
| SELENOMETHIONINE SE 75 | selenomethionine se-75 | GE HEALTHCARE | NDA017257 | |
| SELSUN | selenium sulfide | CHATTEM | NDA007936 | |
| SELZENTRY | maraviroc | VIIV HLTHCARE | NDA022128 | |
| SELZENTRY | maraviroc | VIIV HLTHCARE | NDA208984 | |
| SEMGLEE | insulin glargine | MYLAN PHARMS INC | BLA210605 | |
| SEMGLEE | insulin glargine-yfgn | MYLAN PHARMS INC | BLA761201 | |
| SEMPREX-D | acrivastine, pseudoephedrine hydrochloride | ENDO OPERATIONS | NDA019806 | |
| SENSIPAR | cinacalcet hydrochloride | AMGEN | NDA021688 | |
| SENSORCAINE | bupivacaine hydrochloride, epinephrine bitartrate | FRESENIUS KABI USA | NDA018304 | |
| SEPHIENCE | sepiapterin | PTC THERAP | NDA219666 | |
| SEPTOCAINE | articaine hydrochloride, epinephrine bitartrate | DEPROCO | NDA020971 | |
| SEPTOCAINE | articaine hydrochloride, epinephrine bitartrate | DEPROCO | NDA022010 | |
| SEPTRA | sulfamethoxazole, trimethoprim | MONARCH PHARMS | NDA017376 | |
| SEPTRA | sulfamethoxazole, trimethoprim | MONARCH PHARMS | NDA017598 | |
| SEPTRA | sulfamethoxazole, trimethoprim | MONARCH PHARMS | NDA018452 | |
| SER-AP-ES | hydralazine hydrochloride, hydrochlorothiazide, reserpine | NOVARTIS | NDA012193 | |
| SERAX | oxazepam | ALPHARMA US PHARMS | NDA015539 | |
| SERENTIL | mesoridazine besylate | NOVARTIS | NDA016774 | |
| SERENTIL | mesoridazine besylate | NOVARTIS | NDA016775 | |
| SERENTIL | mesoridazine besylate | NOVARTIS | NDA016997 | |
| SEREVENT | salmeterol xinafoate | GLAXOSMITHKLINE | NDA020236 | |
| SEREVENT | salmeterol xinafoate | GLAXOSMITHKLINE | NDA020692 | |
| SERNIVO | betamethasone dipropionate | PRIMUS PHARMS | NDA208079 | |
| SEROPHENE | clomiphene citrate | EMD SERONO | NDA018361 | |
| SEROQUEL | quetiapine fumarate | CHEPLAPHARM | NDA020639 | |
| SEROQUEL XR | quetiapine fumarate | CHEPLAPHARM | NDA022047 | |
| SEROQUEL XR | quetiapine fumarate | CHEPLAPHARM ARZNEIMITTEL GMBH | NDA022172 | |
| SEROSTIM | somatropin | EMD SERONO | BLA020604 | |
| SERPALAN | reserpine | LANNETT | NDA010124 | |
| SERPASIL | reserpine | NOVARTIS | NDA009115 | |
| SERPASIL | reserpine | NOVARTIS | NDA009434 | |
| SERPASIL-APRESOLINE | hydralazine hydrochloride, reserpine | NOVARTIS | NDA009296 | |
| SERPASIL-ESIDRIX #2 | hydrochlorothiazide, reserpine | NOVARTIS | NDA011878 | |
| SERTRALINE HYDROCHLORIDE | sertraline hydrochloride | ALMATICA | NDA215133 | |
| SERZONE | nefazodone hydrochloride | BRISTOL MYERS SQUIBB | NDA020152 | |
| SESQUIENT | fosphenytoin sodium | LUPIN | NDA210864 | |
| SETHOTOPE | selenomethionine se-75 | BRACCO | NDA017047 | |
| SEYSARA | sarecycline hydrochloride | ALMIRALL | NDA209521 | |
| SEZABY | phenobarbital sodium | SUN PHARM INDS INC | NDA215910 | |
| SHADE UVAGUARD | avobenzone, octinoxate, oxybenzone | BAYER HEALTHCARE LLC | NDA020045 | |
| SIGNIFOR | pasireotide diaspartate | RECORDATI RARE | NDA200677 | |
| SIGNIFOR LAR KIT | pasireotide pamoate | RECORDATI RARE | NDA203255 | |
| SIKLOS | hydroxyurea | THERAVIA | NDA208843 | |
| SILDAFLO | silver sulfadiazine | FRANKLIN PHARMS | NDA019608 | |
| SILENOR | doxepin hydrochloride | CURRAX | NDA022036 | |
| SILIQ | brodalumab | VALEANT LUXEMBOURG | BLA761032 | |
| SILVADENE | silver sulfadiazine | KING PHARMS LLC | NDA017381 | |
| SIMBRINZA | brimonidine tartrate, brinzolamide | ALCON LABS INC | NDA204251 | |
| SIMLANDI | adalimumab-ryvk | ALVOTECH USA INC | BLA761299 | |
| SIMPONI | golimumab | CENTOCOR ORTHO BIOTECH INC | BLA125289 | |
| SIMPONI ARIA | golimumab | JANSSEN BIOTECH | BLA125433 | |
| SIMTRIYO | centanafadine hydrochloride | OTSUKA PHARMACEUTICAL CO LTD | NDA218145 | |
| SIMULECT | basiliximab | NOVARTIS | BLA103764 | |
| SIMVASTATIN | simvastatin | SYNTHON PHARMS | NDA021961 | |
| SINCALIDE | sincalide | MAIA PHARMS INC | NDA210850 | |
| SINE-AID IB | ibuprofen, pseudoephedrine hydrochloride | KENVUE BRANDS | NDA019899 | |
| SINEMET | carbidopa, levodopa | ORGANON | NDA017555 | |
| SINEMET CR | carbidopa, levodopa | ORGANON LLC | NDA019856 | |
| SINEQUAN | doxepin hydrochloride | PFIZER | NDA016798 | |
| SINEQUAN | doxepin hydrochloride | PFIZER | NDA017516 | |
| SINGULAIR | montelukast sodium | ORGANON | NDA020829 | |
| SINGULAIR | montelukast sodium | ORGANON | NDA020830 | |
| SINGULAIR | montelukast sodium | ORGANON | NDA021409 | |
| SINOGRAFIN | diatrizoate meglumine, iodipamide meglumine | BRACCO | NDA011324 | |
| SINUVA | mometasone furoate | INTERSECT ENT INC | NDA209310 | |
| SIRTURO | bedaquiline fumarate | JANSSEN THERAP | NDA204384 | |
| SITAVIG | acyclovir | LIGAND PHARMS | NDA203791 | |
| SIVEXTRO | tedizolid phosphate | CUBIST PHARMS LLC | NDA205435 | |
| SIVEXTRO | tedizolid phosphate | CUBIST PHARMS LLC | NDA205436 | |
| SKELAXIN | metaxalone | KING PHARMS | NDA013217 | |
| SKELID | tiludronate disodium | SANOFI AVENTIS US | NDA020707 | |
| SKIN EXPOSURE REDUCTION PASTE AGAINST CHEMICAL WARFARE AGENTS | perfluoropolymethylisopropyl ether, polytetrafluoroethylene | US ARMY MED RES | NDA021084 | |
| SKLICE | ivermectin | ARBOR PHARMS LLC | NDA202736 | |
| SKYCLARYS | omaveloxolone | BIOGEN US | NDA216718 | |
| SKYLA | levonorgestrel | BAYER HLTHCARE | NDA203159 | |
| SKYRIZI | risankizumab-rzaa | ABBVIE INC | BLA761105 | |
| SKYRIZI | risankizumab-rzaa | ABBVIE INC | BLA761262 | |
| SKYTROFA | lonapegsomatropin-tcgd | ASCENDIS PHARMA ENCOCRINOLOGY DIV A/S | BLA761177 | |
| SLOW-K | potassium chloride | NOVARTIS | NDA017476 | |
| SLYND | drospirenone | EXELTIS USA INC | NDA211367 | |
| SMOFLIPID 20% | fish oil, medium chain triglycerides, olive oil, soybean oil | FRESENIUS KABI USA | NDA207648 | |
| SOAANZ | torsemide | SARFE PHARMS | NDA213218 | |
| SODIUM ACETATE | sodium acetate | HOSPIRA | NDA018893 | |
| SODIUM BICARBONATE | sodium bicarbonate | BAXTER HLTHCARE CORP | NDA218524 | |
| SODIUM BICARBONATE | sodium bicarbonate | AMNEAL | NDA220790 | |
| SODIUM BICARBONATE IN PLASTIC CONTAINER | sodium bicarbonate | ABBOTT | NDA019443 | |
| SODIUM CHLORIDE | sodium chloride | ABBOTT | NDA017013 | |
| SODIUM CHLORIDE | sodium chloride | B BRAUN | NDA017038 | |
| SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | sodium chloride | HOSPIRA | NDA017670 | |
| SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | sodium chloride | BAXTER HLTHCARE | NDA017864 | |
| SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | sodium chloride | BAXTER HLTHCARE | NDA018016 | |
| SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | sodium chloride | OTSUKA ICU MEDCL | NDA018090 | |
| SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | sodium chloride | B BRAUN | NDA018184 | |
| SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | sodium chloride | HOSPIRA | NDA018380 | |
| SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | sodium chloride | HOSPIRA | NDA019759 | |
| SODIUM CHLORIDE 0.9% | sodium chloride | MEDEFIL INC | NDA202832 | |
| SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075% | potassium chloride, sodium chloride | BAXTER HLTHCARE | NDA017648 | |
| SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER | potassium chloride, sodium chloride | B BRAUN | NDA018722 | |
| SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | sodium chloride | OTSUKA ICU MEDCL | NDA016366 | |
| SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | sodium chloride | BAXTER HLTHCARE | NDA016677 | |
| SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | sodium chloride | B BRAUN | NDA016733 | |
| SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | sodium chloride | BAXTER HLTHCARE | NDA017427 | |
| SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | sodium chloride | B BRAUN | NDA017464 | |
| SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | sodium chloride | OTSUKA ICU MEDCL | NDA017514 | |
| SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | sodium chloride | BAXTER HLTHCARE | NDA017867 | |
| SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | sodium chloride | OTSUKA ICU MEDCL | NDA018314 | |
| SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | sodium chloride | HOSPIRA | NDA018803 | |
| SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | sodium chloride | ICU MEDICAL INC | NDA019217 | |
| SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | sodium chloride | HOSPIRA | NDA019465 | |
| SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | sodium chloride | HOSPIRA | NDA019480 | |
| SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | sodium chloride | BAXTER HLTHCARE | NDA020178 | |
| SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | sodium chloride | LIEBEL-FLARSHEIM | NDA021569 | |
| SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER | sodium chloride | BAXTER HLTHCARE | NDA019319 | |
| SODIUM CHLORIDE 14.6% | sodium chloride | HOSPIRA | NDA018897 | |
| SODIUM CHLORIDE 3% IN PLASTIC CONTAINER | sodium chloride | BAXTER HLTHCARE | NDA019022 | |
| SODIUM CHLORIDE 5% IN PLASTIC CONTAINER | sodium chloride | B BRAUN | NDA019635 | |
| SODIUM CHROMATE CR 51 | sodium chromate cr-51 | CURIUM | NDA016708 | |
| SODIUM FLUORIDE F 18 | sodium fluoride f-18 | NIH NCI DCTD | NDA022494 | |
| SODIUM IODIDE I 123 | sodium iodide i-123 | GE HEALTHCARE | NDA017630 | |
| SODIUM IODIDE I 123 | sodium iodide i-123 | CARDINAL HEALTH 418 | NDA018671 | |
| SODIUM IODIDE I 131 | sodium iodide i-131 | CURIUM | NDA016515 | |
| SODIUM IODIDE I 131 | sodium iodide i-131 | CURIUM | NDA016517 | |
| SODIUM IODIDE I 131 | sodium iodide i-131 | SUN PHARM INDS INC | NDA017315 | |
| SODIUM IODIDE I 131 | sodium iodide i-131 | CIS | NDA017316 | |
| SODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINER | sodium lactate | BAXTER HLTHCARE | NDA016692 | |
| SODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINER | sodium lactate | B BRAUN | NDA018186 | |
| SODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINER | sodium lactate | HOSPIRA | NDA018249 | |
| SODIUM LACTATE 1/6 MOLAR IN PLASTIC CONTAINER | sodium lactate | B BRAUN | NDA020004 | |
| SODIUM LACTATE IN PLASTIC CONTAINER | sodium lactate | HOSPIRA | NDA018947 | |
| SODIUM NITRITE | sodium nitrite | HOPE PHARMS | NDA203922 | |
| SODIUM NITROPRUSSIDE | sodium nitroprusside | BAXTER HLTHCARE | NDA018581 | |
| SODIUM PERTECHNETATE TC 99M | technetium tc-99m sodium pertechnetate | SUN PHARM INDS INC | NDA017321 | |
| SODIUM PERTECHNETATE TC 99M | technetium tc-99m sodium pertechnetate | GE HEALTHCARE | NDA017471 | |
| SODIUM PERTECHNETATE TC 99M | technetium tc-99m sodium pertechnetate | MALLINCKRODT | NDA017725 | |
| SODIUM PHENYLACETATE AND SODIUM BENZOATE | sodium benzoate, sodium phenylacetate | MAIA PHARMS INC | NDA215025 | |
| SODIUM PHOSPHATE P 32 | sodium phosphate p-32 | MALLINCKRODT | NDA011777 | |
| SODIUM PHOSPHATES IN PLASTIC CONTAINER | sodium phosphate, dibasic, heptahydrate, sodium phosphate, monobasic, monohydrate | HOSPIRA | NDA018892 | |
| SODIUM POLYPHOSPHATE-TIN KIT | technetium tc-99m polyphosphate kit | GE HEALTHCARE | NDA017664 | |
| SODIUM SULAMYD | sulfacetamide sodium | SCHERING | NDA005963 | |
| SODIUM THIOSULFATE | sodium thiosulfate | US ARMY | NDA020166 | |
| SODIUM THIOSULFATE | sodium thiosulfate | HOPE PHARMS | NDA203923 | |
| SOFDRA | sofpironium bromide | BOTANIX SB | NDA217347 | |
| SOGROYA | somapacitan-beco | NOVO NORDISK INC | BLA761156 | |
| SOHONOS | palovarotene | IPSEN | NDA215559 | |
| SOLAGE | mequinol, tretinoin | ALMIRALL | NDA020922 | |
| SOLARAZE | diclofenac sodium | FOUGERA | NDA021005 | |
| SOLIQUA 100/33 | insulin glargine, lixisenatide | SANOFI-AVENTIS US | BLA208673 | |
| SOLIRIS | eculizumab | ALEXION PHARM | BLA125166 | |
| SOLODYN | minocycline hydrochloride | BAUSCH | NDA050808 | |
| SOLOSEC | secnidazole | EVOFEM INC | NDA209363 | |
| SOLTAMOX | tamoxifen citrate | MAYNE PHARMA COMMRCL | NDA021807 | |
| SOLU-CORTEF | hydrocortisone sodium succinate | PHARMACIA AND UPJOHN | NDA009866 | |
| SOLU-MEDROL | methylprednisolone sodium succinate | PHARMACIA AND UPJOHN | NDA011856 | |
| SOLUPREP S | chlorhexidine gluconate, isopropyl alcohol | SOLVENTUM | NDA208288 | |
| SOMA | carisoprodol | MYLAN SPECIALITY LP | NDA011792 | |
| SOMA COMPOUND | aspirin, carisoprodol | MEDA PHARMS | NDA012365 | |
| SOMA COMPOUND W/ CODEINE | aspirin, carisoprodol, codeine phosphate | MEDA PHARMS | NDA012366 | |
| SOMATULINE DEPOT | lanreotide acetate | IPSEN PHARMA | NDA022074 | |
| SOMAVERT | pegvisomant | PHARMACIA | BLA021106 | |
| SONATA | zaleplon | PFIZER | NDA020859 | |
| SONORX | simethicone-cellulose | BRACCO | NDA020773 | |
| SOOLANTRA | ivermectin | GALDERMA LABS LP | NDA206255 | |
| SORBITOL 3% IN PLASTIC CONTAINER | sorbitol | BAXTER HLTHCARE | NDA017863 | |
| SORBITOL 3.3% IN PLASTIC CONTAINER | sorbitol | B BRAUN | NDA016741 | |
| SORBITOL-MANNITOL IN PLASTIC CONTAINER | mannitol, sorbitol | HOSPIRA | NDA017636 | |
| SORBITOL-MANNITOL IN PLASTIC CONTAINER | mannitol, sorbitol | OTSUKA ICU MEDCL | NDA018316 | |
| SORBITRATE | isosorbide dinitrate | ASTRAZENECA | NDA016192 | |
| SORBITRATE | isosorbide dinitrate | ASTRAZENECA | NDA016776 | |
| SORIATANE | acitretin | STIEFEL LABS INC | NDA019821 | |
| SORILUX | calcipotriene | MAYNE PHARMA | NDA022563 | |
| SOTALOL HYDROCHLORIDE | sotalol hydrochloride | ALTATHERA PHARMS LLC | NDA022306 | |
| SOTRADECOL | sodium tetradecyl sulfate | ELKINS SINN | NDA005970 | |
| SOTYKTU | deucravacitinib | BRISTOL | NDA214958 | |
| SOTYLIZE | sotalol hydrochloride | AZURITY | NDA205108 | |
| SOVALDI | sofosbuvir | GILEAD SCIENCES INC | NDA204671 | |
| SOVALDI | sofosbuvir | GILEAD SCIENCES INC | NDA212480 | |
| SOVUNA | hydroxychloroquine sulfate | NOVITIUM PHARMA | NDA214581 | |
| SOYACAL 10% | soybean oil | ALPHA THERA | NDA018465 | |
| SOYACAL 20% | soybean oil | ALPHA THERA | NDA018786 | |
| SPARINE | promazine hydrochloride | WYETH AYERST | NDA010348 | |
| SPARINE | promazine hydrochloride | HIKMA | NDA010349 | |
| SPARINE | promazine hydrochloride | WYETH AYERST | NDA010942 | |
| SPECTAMINE | iofetamine hydrochloride i-123 | IMP | NDA019432 | |
| SPECTAZOLE | econazole nitrate | ALVOGEN | NDA018751 | |
| SPECTRACEF | cefditoren pivoxil | VANSEN PHARMA | NDA021222 | |
| SPECTROBID | bacampicillin hydrochloride | PFIZER | NDA050520 | |
| SPECTROBID | bacampicillin hydrochloride | PFIZER | NDA050556 | |
| SPEVIGO | spesolimab-sbzo | BOEHRINGER INGELHEIM PHARMACEUTICALS INC | BLA761244 | |
| SPINRAZA | nusinersen sodium | BIOGEN | NDA209531 | |
| SPIRIVA | tiotropium bromide | BOEHRINGER INGELHEIM | NDA021395 | |
| SPIRIVA RESPIMAT | tiotropium bromide | BOEHRINGER INGELHEIM | NDA021936 | |
| SPIRIVA RESPIMAT | tiotropium bromide | BOEHRINGER INGELHEIM | NDA207070 | |
| SPORANOX | itraconazole | JANSSEN PHARMS | NDA020083 | |
| SPORANOX | itraconazole | JANSSEN PHARMS | NDA020657 | |
| SPORANOX | itraconazole | JANSSEN PHARMA | NDA020694 | |
| SPORANOX | itraconazole | JANSSEN PHARMS | NDA020966 | |
| SPRAVATO | esketamine hydrochloride | JANSSEN PHARMS | NDA211243 | |
| SPRITAM | levetiracetam | APRECIA PHARMS | NDA207958 | |
| SPRIX | ketorolac tromethamine | COSETTE | NDA022382 | |
| SPRYCEL | dasatinib | BRISTOL MYERS SQUIBB | NDA021986 | |
| SPRYCEL | dasatinib | BRISTOL MYERS SQUIBB | NDA022072 | |
| SPY AGENT GREEN KIT | indocyanine green | NOVADAQ TECH | NDA211580 | |
| SSD AF | silver sulfadiazine | DR REDDYS | NDA018578 | |
| STADOL | butorphanol tartrate | APOTHECON | NDA017857 | |
| STADOL | butorphanol tartrate | BRISTOL MYERS SQUIBB | NDA019890 | |
| STALEVO 75 | carbidopa, entacapone, levodopa | ORION PHARMA | NDA021485 | |
| STARJEMZA | ustekinumab-hmny | BIO-THERA SOLUTIONS LTD | BLA761419 | |
| STARLIX | nateglinide | NOVARTIS | NDA021204 | |
| STATICIN | erythromycin | WESTWOOD SQUIBB | NDA050526 | |
| STATROL | neomycin sulfate, polymyxin b sulfate | ALCON | NDA050344 | |
| STATROL | neomycin sulfate, polymyxin b sulfate | ALCON | NDA050456 | |
| STAVZOR | valproic acid | BIONPHARMA | NDA022152 | |
| STAXYN | vardenafil hydrochloride | BAYER HLTHCARE | NDA200179 | |
| STEGLATRO | ertugliflozin | MSD SUB MERCK | NDA209803 | |
| STEGLUJAN | ertugliflozin, sitagliptin phosphate | MSD SUB MERCK | NDA209805 | |
| STELARA | ustekinumab | CENTOCOR ORTHO BIOTECH INC | BLA125261 | |
| STELARA | ustekinumab | JANSSEN BIOTECH | BLA761044 | |
| STELAZINE | trifluoperazine hydrochloride | GLAXOSMITHKLINE | NDA011552 | |
| STENDRA | avanafil | VIVUS LLC | NDA202276 | |
| STEQEYMA | ustekinumab-stba | CELLTRION, INC. | BLA761338 | |
| STERANE | prednisolone | PFIZER | NDA009996 | |
| STERANE | prednisolone acetate | PFIZER | NDA011446 | |
| STERILE UREA | urea | HOSPIRA | NDA017698 | |
| STERILE WATER | sterile water for irrigation | BAXTER HLTHCARE | NDA017428 | |
| STERILE WATER FOR INJECTION | sterile water for injection | HOSPIRA | NDA018801 | |
| STERILE WATER FOR INJECTION IN PLASTIC CONTAINER | sterile water for injection | OTSUKA ICU MEDCL | NDA018233 | |
| STERILE WATER FOR INJECTION IN PLASTIC CONTAINER | sterile water for injection | BAXTER HLTHCARE | NDA018632 | |
| STERILE WATER FOR INJECTION IN PLASTIC CONTAINER | sterile water for injection | B BRAUN | NDA019077 | |
| STERILE WATER FOR INJECTION IN PLASTIC CONTAINER | sterile water for injection | B BRAUN | NDA019633 | |
| STERILE WATER FOR INJECTION IN PLASTIC CONTAINER | sterile water for injection | OTSUKA ICU MEDCL | NDA019869 | |
| STERILE WATER IN PLASTIC CONTAINER | sterile water for irrigation | B BRAUN | NDA016734 | |
| STERILE WATER IN PLASTIC CONTAINER | sterile water for irrigation | OTSUKA ICU MEDCL | NDA017513 | |
| STERILE WATER IN PLASTIC CONTAINER | sterile water for irrigation | BAXTER HLTHCARE | NDA017866 | |
| STERILE WATER IN PLASTIC CONTAINER | sterile water for irrigation | OTSUKA ICU MEDCL | NDA018313 | |
| STERITALC | talc | NOVATECH SA | NDA205555 | |
| STIMATE | desmopressin acetate | FERRING PHARMS INC | NDA020355 | |
| STIMUFEND | pegfilgrastim-fpgk | FRESENIUS KABI USA | BLA761173 | |
| STIOLTO RESPIMAT | olodaterol hydrochloride, tiotropium bromide | BOEHRINGER INGELHEIM | NDA206756 | |
| STIVARGA | regorafenib | BAYER HLTHCARE | NDA203085 | |
| STIVARGA | regorafenib | BAYER HEALTHCARE PHARMS | NDA204369 | |
| STOXIL | idoxuridine | GLAXOSMITHKLINE | NDA013934 | |
| STOXIL | idoxuridine | GLAXOSMITHKLINE | NDA015868 | |
| STRATTERA | atomoxetine hydrochloride | LILLY | NDA021411 | |
| STRENSIQ | asfotase alfa | ALEXION PHARM | BLA125513 | |
| STRIANT | testosterone | AUXILIUM PHARMS LLC | NDA021543 | |
| STRIBILD | cobicistat, elvitegravir, emtricitabine, tenofovir disoproxil fumarate | GILEAD SCIENCES INC | NDA203100 | |
| STRIVERDI RESPIMAT | olodaterol hydrochloride | BOEHRINGER INGELHEIM | NDA203108 | |
| STROMECTOL | ivermectin | MERCK SHARP DOHME | NDA050742 | |
| SUBLIMAZE PRESERVATIVE FREE | fentanyl citrate | RISING | NDA016619 | |
| SUBLOCADE | buprenorphine | INDIVIOR | NDA209819 | |
| SUBOXONE | buprenorphine hydrochloride, naloxone hydrochloride | INDIVIOR | NDA020733 | |
| SUBOXONE | buprenorphine hydrochloride, naloxone hydrochloride | INDIVIOR | NDA022410 | |
| SUBSYS | fentanyl | BTCP PHARMA | NDA202788 | |
| SUBUTEX | buprenorphine hydrochloride | INDIVIOR | NDA020732 | |
| SUBVENITE | lamotrigine | OWP PHARMS | NDA218879 | |
| SUCCINYLCHOLINE CHLORIDE | succinylcholine chloride | HIKMA | NDA215143 | |
| SUCLEAR | magnesium sulfate, polyethylene glycol 3350, potassium chloride, potassium sulfate, sodium bicarbonate, sodium chloride, sodium sulfate | BRAINTREE LABS | NDA203595 | |
| SUCOSTRIN | succinylcholine chloride | APOTHECON | NDA008847 | |
| SUCRAID | sacrosidase | QOL MEDCL | BLA020772 | |
| SUDAFED 24 HOUR | pseudoephedrine hydrochloride | KENVUE BRANDS | NDA020021 | |
| SUFENTA PRESERVATIVE FREE | sufentanil citrate | RISING | NDA019050 | |
| SUFLAVE | magnesium sulfate, polyethylene glycol 3350, potassium chloride, sodium chloride, sodium sulfate | AZURITY | NDA215344 | |
| SULAR | nisoldipine | AZURITY | NDA020356 | |
| SULFADIAZINE | sulfadiazine, sulfadiazine sodium | LEDERLE | NDA004054 | |
| SULFADIAZINE | sulfadiazine | LILLY | NDA004122 | |
| SULFAMETHOXAZOLE AND TRIMETHOPRIM | sulfamethoxazole, trimethoprim | TEVA | NDA018242 | |
| SULFAMETHOXAZOLE AND TRIMETHOPRIM | sulfamethoxazole, trimethoprim | TEVA | NDA018812 | |
| SULFAMETHOXAZOLE AND TRIMETHOPRIM | sulfamethoxazole, trimethoprim | WATSON LABS | NDA018852 | |
| SULFAMETHOXAZOLE AND TRIMETHOPRIM AND PHENAZOPYRIDINE HYDROCHLORIDE | phenazopyridine hydrochloride, sulfamethoxazole, trimethoprim | ABLE | NDA021105 | |
| SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH | sulfamethoxazole, trimethoprim | FOSUN PHARMA | NDA018598 | |
| SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH | sulfamethoxazole, trimethoprim | WATSON LABS | NDA018854 | |
| SULFAMYLON | mafenide acetate | RISING | NDA016763 | |
| SULFAMYLON | mafenide acetate | MYLAN INSTITUTIONAL | NDA019832 | |
| SULFAPYRIDINE | sulfapyridine | LILLY | NDA000159 | |
| SULFATRIM | sulfamethoxazole, trimethoprim | PHARM ASSOC | NDA018615 | |
| SULLA | sulfameter | BAYER HLTHCARE | NDA016000 | |
| SULTRIN | triple sulfa (sulfabenzamide, sulfacetamide, sulfathiazole) | ORTHO MCNEIL PHARM | NDA005794 | |
| SUMAVEL DOSEPRO | sumatriptan succinate | ENDO OPERATIONS | NDA022239 | |
| SUNLENCA | lenacapavir sodium | GILEAD SCIENCES INC | NDA215973 | |
| SUNLENCA | lenacapavir sodium | GILEAD SCIENCES INC | NDA215974 | |
| SUNOSI | solriamfetol hydrochloride | AXSOME MALTA | NDA211230 | |
| SUPPRELIN | histrelin acetate | SHIRE | NDA019836 | |
| SUPPRELIN LA | histrelin acetate | ENDO OPERATIONS | NDA022058 | |
| SUPRANE | desflurane | BAXTER HLTHCARE | NDA020118 | |
| SUPRAX | cefixime | LEDERLE | NDA050621 | |
| SUPRAX | cefixime | LEDERLE | NDA050622 | |
| SUPRAX | cefixime | LUPIN LTD | NDA202091 | |
| SUPRAX | cefixime | LUPIN LTD | NDA203195 | |
| SUPRENZA | phentermine hydrochloride | CITIUS PHARMS | NDA202088 | |
| SUPREP BOWEL PREP KIT | magnesium sulfate, potassium sulfate, sodium sulfate | AZURITY | NDA022372 | |
| SURFAXIN | lucinactant | LEES PHARM HK | NDA021746 | |
| SURITAL | thiamylal sodium | PARKEDALE | NDA007600 | |
| SURMONTIL | trimipramine maleate | TEVA WOMENS | NDA016792 | |
| SURVANTA | beractant | ABBVIE | BLA020032 | |
| SUS-PHRINE SULFITE FREE | epinephrine | FOREST LABS | NDA007942 | |
| SUSTIVA | efavirenz | BRISTOL MYERS SQUIBB | NDA020972 | |
| SUSTIVA | efavirenz | BRISTOL MYERS SQUIBB | NDA021360 | |
| SUSTOL | granisetron | HERON THERAPS INC | NDA022445 | |
| SUSVIMO | ranibizumab | GENENTECH INC | BLA761197 | |
| SUTAB | magnesium sulfate, potassium chloride, sodium sulfate | AZURITY | NDA213135 | |
| SUTENT | sunitinib malate | CPPI CV | NDA021938 | |
| SUTENT | sunitinib malate | CPPI CV | NDA021968 | |
| SYFOVRE | pegcetacoplan | APELLIS PHARMS | NDA217171 | |
| SYLVANT | siltuximab | RECORDATI RARE DISEASES, INC. | BLA125496 | |
| SYMBICORT | budesonide, formoterol fumarate dihydrate | ASTRAZENECA | NDA021929 | |
| SYMBICORT AEROSPHERE | budesonide, formoterol fumarate | ASTRAZENECA | NDA216579 | |
| SYMBRAVO | meloxicam, rizatriptan benzoate | AXSOME | NDA215431 | |
| SYMBYAX | fluoxetine hydrochloride, olanzapine | LILLY | NDA021520 | |
| SYMDEKO (COPACKAGED) | ivacaftor, ivacaftor, tezacaftor | VERTEX PHARMS INC | NDA210491 | |
| SYMFI | efavirenz, lamivudine, tenofovir disoproxil fumarate | MYLAN LABS LTD | NDA022142 | |
| SYMFI LO | efavirenz, lamivudine, tenofovir disoproxil fumarate | MYLAN | NDA208255 | |
| SYMJEPI | epinephrine | ADAMIS PHARMS CORP | NDA207534 | |
| SYMLIN | pramlintide acetate | ASTRAZENECA AB | NDA021332 | |
| SYMMETREL | amantadine hydrochloride | ENDO PHARMS | NDA016023 | |
| SYMMETREL | amantadine hydrochloride | ENDO PHARMS | NDA017118 | |
| SYMMETREL | amantadine hydrochloride | ENDO PHARMS | NDA018101 | |
| SYMPAZAN | clobazam | COSETTE | NDA210833 | |
| SYMPROIC | naldemedine tosylate | BDSI | NDA208854 | |
| SYMTUZA | cobicistat, darunavir, emtricitabine, tenofovir alafenamide fumarate | JANSSEN PRODS | NDA210455 | |
| SYNAGIS | palivizumab | SWEDISH ORPHAN | BLA103770 | |
| SYNALAR | fluocinolone acetonide | EUROFARMA | NDA012787 | |
| SYNALAR | fluocinolone acetonide | EUROFARMA | NDA013960 | |
| SYNALAR | fluocinolone acetonide | EUROFARMA | NDA015296 | |
| SYNALAR-HP | fluocinolone acetonide | EUROFARMA | NDA016161 | |
| SYNALGOS-DC | aspirin, caffeine, dihydrocodeine bitartrate | SUN PHARM INDUSTRIES | NDA011483 | |
| SYNAREL | nafarelin acetate | PFIZER | NDA019886 | |
| SYNDROS | dronabinol | WELLHOUSE PHARMA | NDA205525 | |
| SYNERA | lidocaine, tetracaine | GALEN SPECIALTY | NDA021623 | |
| SYNERCID | quinupristin, dalfopristin | KING PHARMS | NDA050747 | |
| SYNERCID | dalfopristin, quinupristin | KING PHARMS | NDA050748 | |
| SYNJARDY | empagliflozin, metformin hydrochloride | BOEHRINGER INGELHEIM | NDA206111 | |
| SYNJARDY XR | empagliflozin, metformin hydrochloride | BOEHRINGER INGELHEIM | NDA208658 | |
| SYNKAYVITE | menadiol sodium diphosphate | ROCHE | NDA003718 | |
| SYNOPHYLATE | theophylline sodium glycinate | CENT PHARMS | NDA006333 | |
| SYNRIBO | omacetaxine mepesuccinate | TEVA PHARMS INTL | NDA203585 | |
| SYNTHETIC CONJUGATED ESTROGENS A | estrogens, conjugated synthetic a | TEVA WOMENS | NDA021788 | |
| SYNTHROID | levothyroxine sodium | ABBVIE | NDA021402 | |
| SYNTOCINON | oxytocin | NOVARTIS | NDA018245 | |
| SYPRINE | trientine hydrochloride | BAUSCH | NDA019194 |