All FDA drug approvals
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FDA drug approvals — brands starting with K
93 FDA applications with an approved original submission carry a brand starting with K, the earliest approved in 1955 and the most recent in 2025. FDA marks 31 of them discontinued, every product under the application. From the Drugs@FDA export of 2026-09-03.
| Brand | Ingredient | Approved | Sponsor | Application |
|---|---|---|---|---|
| K-TAB | potassium chloride | ABBVIE | NDA018279 | |
| KABIVEN IN PLASTIC CONTAINER | amino acids, calcium chloride, dextrose, magnesium sulfate, potassium chloride, sodium acetate, sodium glycerophosphate, soybean oil | FRESENIUS KABI USA | NDA200656 | |
| KADCYLA | ado-trastuzumab emtansine | GENENTECH | BLA125427 | |
| KADIAN | morphine sulfate | ALLERGAN | NDA020616 | |
| KAFOCIN | cephaloglycin | LILLY | NDA050219 | |
| KALBITOR | ecallantide | DYAX CORP. | BLA125277 | |
| KALETRA | lopinavir, ritonavir | ABBVIE | NDA021226 | |
| KALETRA | lopinavir, ritonavir | ABBVIE | NDA021251 | |
| KALETRA | lopinavir, ritonavir | ABBVIE | NDA021906 | |
| KALYDECO | ivacaftor | VERTEX PHARMS | NDA203188 | |
| KALYDECO | ivacaftor | VERTEX PHARMS INC | NDA207925 | |
| KANJINTI | trastuzumab-anns | AMGEN INC | BLA761073 | |
| KANUMA | sebelipase alfa | ALEXION PHARM | BLA125561 | |
| KAPSPARGO SPRINKLE | metoprolol succinate | SPIL | NDA210428 | |
| KAPVAY | clonidine hydrochloride | CONCORDIA PHARMS INC | NDA022331 | |
| KARBINAL ER | carbinoxamine maleate | AYTU | NDA022556 | |
| KATERZIA | amlodipine benzoate | AZURITY | NDA211340 | |
| KAYEXALATE | sodium polystyrene sulfonate | CONCORDIA | NDA011287 | |
| KAZANO | alogliptin benzoate, metformin hydrochloride | TAKEDA PHARMS USA | NDA203414 | |
| KEFLET | cephalexin | LILLY | NDA050440 | |
| KEFLEX | cephalexin | PRAGMA | NDA050405 | |
| KEFLEX | cephalexin | PRAGMA | NDA050406 | |
| KEFLIN | cephalothin sodium | LILLY | NDA050482 | |
| KEFTAB | cephalexin hydrochloride | LILLY | NDA050614 | |
| KEMADRIN | procyclidine hydrochloride | MONARCH PHARMS | NDA009818 | |
| KEMSTRO | baclofen | UCB INC | NDA021589 | |
| KENACORT | triamcinolone | DELCOR ASSET CORP | NDA011283 | |
| KENACORT | triamcinolone diacetate | DELCOR ASSET CORP | NDA012515 | |
| KENALOG | triamcinolone acetonide | SUN PHARM INDS INC | NDA012104 | |
| KENALOG IN ORABASE | triamcinolone acetonide | DELCOR ASSET CORP | NDA012097 | |
| KENALOG-10 | triamcinolone acetonide | APOTHECON | NDA012041 | |
| KENALOG-40 | triamcinolone acetonide | APOTHECON | NDA014901 | |
| KENGREAL | cangrelor | CHIESI | NDA204958 | |
| KEPIVANCE | palifermin | BIOVITRUM AB | BLA125103 | |
| KEPPRA | levetiracetam | UCB INC | NDA021035 | |
| KEPPRA | levetiracetam | UCB INC | NDA021505 | |
| KEPPRA | levetiracetam | UCB INC | NDA021872 | |
| KEPPRA XR | levetiracetam | UCB INC | NDA022285 | |
| KERENDIA | finerenone | BAYER HLTHCARE | NDA215341 | |
| KERLEDEX | betaxolol hydrochloride, chlorthalidone | SANOFI AVENTIS US | NDA019807 | |
| KERLONE | betaxolol hydrochloride | SANOFI AVENTIS US | NDA019507 | |
| KERYDIN | tavaborole | ANACOR PHARMS INC | NDA204427 | |
| KESIMPTA | ofatumumab | NOVARTIS | BLA125326 | |
| KETALAR | ketamine hydrochloride | PH HEALTH | NDA016812 | |
| KETEK | telithromycin | SANOFI AVENTIS US | NDA021144 | |
| KEVEYIS | dichlorphenamide | XERIS | NDA011366 | |
| KEVZARA | sarilumab | SANOFI SYNTHELABO | BLA761037 | |
| KEYTRUDA | pembrolizumab | MERCK SHARP DOHME | BLA125514 | |
| KEYTRUDA QLEX | pembrolizumab, berahyaluronidase alfa-pmph | MERCK SHARP DOHME | BLA761467 | |
| KHAPZORY | levoleucovorin | ACROTECH BIOPHARMA | NDA211226 | |
| KHEDEZLA | desvenlafaxine | OSMOTICA PHARM CORP | NDA204683 | |
| KHINDIVI | hydrocortisone | ETON | NDA218980 | |
| KIMMTRAK | tebentafusp-tebn | IMMUNOCORE LTD | BLA761228 | |
| KIMYRSA | oritavancin diphosphate | MELINTA THERAP | NDA214155 | |
| KINERET | anakinra | BIOVITRUM AB | BLA103950 | |
| KINEVAC | sincalide | BRACCO | NDA017697 | |
| KINLYTIC | urokinase | MICROBIX BIOSYSTEMS | BLA021846 | |
| KIRSTY | insulin aspart-xjhz | BIOCON BIOLOGICS INC | BLA761188 | |
| KISQALI | ribociclib succinate | NOVARTIS | NDA209092 | |
| KISQALI FEMARA CO-PACK (COPACKAGED) | letrozole, ribociclib succinate | NOVARTIS | NDA209935 | |
| KISUNLA | donanemab-azbt | ELI LILLY CO | BLA761248 | |
| KITABIS PAK | tobramycin | PULMOFLOW INC | NDA205433 | |
| KLARON | sulfacetamide sodium | BAUSCH | NDA019931 | |
| KLISYRI | tirbanibulin | ALMIRALL | NDA213189 | |
| KLONOPIN | clonazepam | CHEPLAPHARM | NDA017533 | |
| KLONOPIN RAPIDLY DISINTEGRATING | clonazepam | ROCHE | NDA020813 | |
| KLOR-CON | potassium chloride | UPSHER SMITH LABS | NDA019123 | |
| KLOTRIX | potassium chloride | APOTHECON | NDA017850 | |
| KLOXXADO | naloxone hydrochloride | HIKMA | NDA212045 | |
| KOMBIGLYZE XR | metformin hydrochloride, saxagliptin hydrochloride | ASTRAZENECA AB | NDA200678 | |
| KOMZIFTI | ziftomenib | KURA | NDA220305 | |
| KONVOMEP | omeprazole, sodium bicarbonate | AZURITY | NDA213593 | |
| KORLYM | mifepristone | CORCEPT THERAP | NDA202107 | |
| KORSUVA | difelikefalin acetate | VIFOR INTL | NDA214916 | |
| KOSELUGO | selumetinib sulfate | ASTRAZENECA | NDA213756 | |
| KOSELUGO | selumetinib, selumetinib sulfate | ASTRAZENECA | NDA219943 | |
| KOVANAZE | oxymetazoline hydrochloride, tetracaine hydrochloride | ST RENATUS | NDA208032 | |
| KRAZATI | adagrasib | BRISTOL | NDA216340 | |
| KRINTAFEL | tafenoquine succinate | GLAXOSMITHKLINE | NDA210795 | |
| KRYSTEXXA | pegloticase | HORIZON PHARMA | BLA125293 | |
| KUVAN | sapropterin dihydrochloride | BIOMARIN PHARM | NDA022181 | |
| KUVAN | sapropterin dihydrochloride | BIOMARIN PHARM | NDA205065 | |
| KYBELLA | deoxycholic acid | ABBVIE | NDA206333 | |
| KYGEVVI | doxecitine, doxribtimine | UCB INC | NDA219792 | |
| KYLEENA | levonorgestrel | BAYER HLTHCARE | NDA208224 | |
| KYNAMRO | mipomersen sodium | KASTLE THERAPS LLC | NDA203568 | |
| KYNMOBI | apomorphine hydrochloride | SUMITOMO PHARMA AM | NDA210875 | |
| KYPROLIS | carfilzomib | ONYX PHARMS AMGEN | NDA202714 | |
| KYTRIL | granisetron hydrochloride | ROCHE | NDA020239 | |
| KYTRIL | granisetron hydrochloride | ROCHE | NDA020305 | |
| KYTRIL | granisetron hydrochloride | ROCHE | NDA021238 | |
| KYXATA | carboplatin | AVYXA HOLDINGS | NDA219921 | |
| KYZATREX | testosterone undecanoate | MARIUS | NDA213953 |