Eli Lilly and Company

Eli Lilly and Company (LLY)

FDA Applications

Note: This list only includes applications that have been responded to by the FDA.

ApplicationProduct NameActive IngredientFormStrengthStatus
BLA761306 - ELI LILLY AND CO
EBGLYSSLEBRIKIZUMAB-LBKZINJECTABLE;INJECTION250MG/2MLPrescription
BLA761279 - ELI LILLY AND CO
OMVOHMIRIKIZUMAB-MRKZVIAL; SINGLE-USE300MG/15MLPrescription
OMVOHMIRIKIZUMAB-MRKZINJECTABLE;SUBCUTANEOUS100MG/MLPrescription
BLA761248 - ELI LILLY CO
KISUNLADONANEMAB-AZBTINJECTABLE;INJECTION350MG/20ML(17.5MG/ML)Prescription
BLA761215 - ELI LILLY CO
REZVOGLARINSULIN GLARGINE-AGLRINJECTABLE;INJECTION3ML(100UNITS/ML)Prescription
BLA761109 - ELI LILLY AND CO
LYUMJEVINSULIN LISPRO-AABCINJECTABLE;INJECTION100UNITS/ML(U-100)Prescription
LYUMJEVINSULIN LISPRO-AABCINJECTABLE;INJECTION200UNITS/ML(U-200)Prescription
BLA761063 - ELI LILLY AND CO
EMGALITYGALCANEZUMAB-GNLMINJECTABLE;INJECTION120MG/MLPrescription
BLA761038 - ELI LILLY AND CO
LARTRUVOOLARATUMABINJECTABLE; INJECTION500MG/50MLPrescription
NDA218160 - LOXO ONCOL ELI LILLY
RETEVMOSELPERCATINIBCAPSULE;ORAL80MGPrescription
RETEVMOSELPERCATINIBTABLET;ORAL40MGPrescription
RETEVMOSELPERCATINIBTABLET;ORAL80MGPrescription
RETEVMOSELPERCATINIBTABLET;ORAL120MGPrescription
RETEVMOSELPERCATINIBTABLET;ORAL160MGPrescription
RETEVMOSELPERCATINIBCAPSULE;ORAL40MGPrescription
NDA217806 - ELI LILLY AND CO
ZEPBOUND (AUTOINJECTOR)TIRZEPATIDESOLUTION;SUBCUTANEOUS2.5MG/0.5ML (2.5MG/0.5ML)Prescription
ZEPBOUND (AUTOINJECTOR)TIRZEPATIDESOLUTION;SUBCUTANEOUS5MG/0.5ML (5MG/0.5ML)Prescription
ZEPBOUND (AUTOINJECTOR)TIRZEPATIDESOLUTION;SUBCUTANEOUS7.5MG/0.5ML (7.5MG/0.5ML)Prescription
ZEPBOUND (AUTOINJECTOR)TIRZEPATIDESOLUTION;SUBCUTANEOUS10MG/0.5ML (10MG/0.5ML)Prescription
ZEPBOUND (AUTOINJECTOR)TIRZEPATIDESOLUTION;SUBCUTANEOUS12.5MG/0.5ML (12.5MG/0.5ML)Prescription
ZEPBOUND (AUTOINJECTOR)TIRZEPATIDESOLUTION;SUBCUTANEOUS15MG/0.5ML (15MG/0.5ML)Prescription
ZEPBOUNDTIRZEPATIDESOLUTION;SUBCUTANEOUS2.5MG/0.5ML (2.5MG/0.5ML)Prescription
ZEPBOUNDTIRZEPATIDESOLUTION;SUBCUTANEOUS5MG/0.5ML (5MG/0.5ML)Prescription
ZEPBOUNDTIRZEPATIDESOLUTION;SUBCUTANEOUS7.5MG/0.5ML (7.5MG/0.5ML)Prescription
ZEPBOUNDTIRZEPATIDESOLUTION;SUBCUTANEOUS10MG/0.5ML (10MG/0.5ML)Prescription
ZEPBOUNDTIRZEPATIDESOLUTION;SUBCUTANEOUS12.5MG/0.5ML (12.5MG/0.5ML)Prescription
ZEPBOUNDTIRZEPATIDESOLUTION;SUBCUTANEOUS15MG/0.5ML (15MG/0.5ML)Prescription
NDA215866 - ELI LILLY AND CO
MOUNJARO (AUTOINJECTOR)TIRZEPATIDESOLUTION;SUBCUTANEOUS10MG/0.5ML (10MG/0.5ML)Prescription
MOUNJARO (AUTOINJECTOR)TIRZEPATIDESOLUTION;SUBCUTANEOUS12.5MG/0.5ML (12.5MG/0.5ML)Prescription
MOUNJARO (AUTOINJECTOR)TIRZEPATIDESOLUTION;SUBCUTANEOUS15MG/0.5ML (15MG/0.5ML)Prescription
MOUNJAROTIRZEPATIDESOLUTION;SUBCUTANEOUS2.5MG/0.5ML (2.5MG/0.5ML)Prescription
MOUNJAROTIRZEPATIDESOLUTION;SUBCUTANEOUS5MG/0.5ML (5MG/0.5ML)Prescription
MOUNJAROTIRZEPATIDESOLUTION;SUBCUTANEOUS7.5MG/0.5ML (7.5MG/0.5ML)Prescription
MOUNJAROTIRZEPATIDESOLUTION;SUBCUTANEOUS10MG/0.5ML (10MG/0.5ML)Prescription
MOUNJAROTIRZEPATIDESOLUTION;SUBCUTANEOUS12.5MG/0.5ML (12.5MG/0.5ML)Prescription
MOUNJAROTIRZEPATIDESOLUTION;SUBCUTANEOUS15MG/0.5ML (15MG/0.5ML)Prescription
MOUNJARO (AUTOINJECTOR)TIRZEPATIDESOLUTION;SUBCUTANEOUS2.5MG/0.5ML (2.5MG/0.5ML)Prescription
MOUNJARO (AUTOINJECTOR)TIRZEPATIDESOLUTION;SUBCUTANEOUS5MG/0.5ML (5MG/0.5ML)Prescription
MOUNJARO (AUTOINJECTOR)TIRZEPATIDESOLUTION;SUBCUTANEOUS7.5MG/0.5ML (7.5MG/0.5ML)Prescription
NDA213246 - LOXO ONCOL ELI LILLY
RETEVMOSELPERCATINIBCAPSULE;ORAL80MGPrescription
RETEVMOSELPERCATINIBCAPSULE;ORAL40MGPrescription
NDA211280 - ELI LILLY AND CO
REYVOWLASMIDITAN SUCCINATETABLET;ORALEQ 50MG BASEPrescription
REYVOWLASMIDITAN SUCCINATETABLET;ORALEQ 200MG BASEDiscontinued
REYVOWLASMIDITAN SUCCINATETABLET;ORALEQ 100MG BASEPrescription
NDA208855 - ELI LILLY AND CO
VERZENIOABEMACICLIBTABLET;ORAL150MGPrescription
VERZENIOABEMACICLIBTABLET;ORAL100MGPrescription
VERZENIOABEMACICLIBTABLET;ORAL200MGPrescription
VERZENIOABEMACICLIBTABLET;ORAL50MGPrescription
NDA208716 - ELI LILLY AND CO
VERZENIOABEMACICLIBTABLET;ORAL100MGPrescription
VERZENIOABEMACICLIBTABLET;ORAL150MGPrescription
VERZENIOABEMACICLIBTABLET;ORAL50MGPrescription
VERZENIOABEMACICLIBTABLET;ORAL200MGPrescription
NDA207924 - ELI LILLY AND CO
OLUMIANTBARICITINIBTABLET;ORAL4MGPrescription
OLUMIANTBARICITINIBTABLET;ORAL1MGPrescription
OLUMIANTBARICITINIBTABLET;ORAL2MGPrescription
BLA205747 - ELI LILLY AND CO
HUMALOG KWIKPENINSULIN LISPRO RECOMBINANTSOLUTION;SUBCUTANEOUS200 UNITS/MLPrescription
BLA205692 - ELI LILLY AND CO
BASAGLARINSULIN GLARGINESOLUTION;SUBCUTANEOUS300 UNITS/3ML (100 UNITS/ML)Prescription
BLA125547 - ELI LILLY CO
PORTRAZZANECITUMUMABINJECTABLE;INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREAL800MG/50MLPrescription
BLA125521 - ELI LILLY AND CO
TALTZIXEKIZUMABINJECTABLE;INJECTION80MG/MLPrescription
BLA125477 - ELI LILLY AND CO
CYRAMZARAMUCIRUMABINJECTABLE;INJECTION100MG/10MLPrescription
CYRAMZARAMUCIRUMABINJECTABLE;INJECTION500MG/50MLPrescription
BLA125469 - ELI LILLY AND CO
TRULICITYDULAGLUTIDEINJECTABLE;INJECTION0.75MG/0.5MLPrescription
TRULICITYDULAGLUTIDEINJECTABLE;INJECTION1.5MG/0.5MLPrescription
TRULICITYDULAGLUTIDEINJECTABLE;INJECTION4.5MG/0.5MLPrescription
TRULICITYDULAGLUTIDEINJECTABLE;INJECTION3MG/0.5MLPrescription
ANDA086530 - LILLY
SECONAL SODIUMSECOBARBITAL SODIUMSUPPOSITORY;RECTAL30MGDiscontinued
SECONAL SODIUMSECOBARBITAL SODIUMSUPPOSITORY;RECTAL60MGDiscontinued
SECONAL SODIUMSECOBARBITAL SODIUMSUPPOSITORY;RECTAL120MGDiscontinued
SECONAL SODIUMSECOBARBITAL SODIUMSUPPOSITORY;RECTAL200MGDiscontinued
ANDA085103 - LILLY
QUINIDINE SULFATEQUINIDINE SULFATECAPSULE;ORAL200MGDiscontinued
ANDA085038 - LILLY
QUINIDINE SULFATEQUINIDINE SULFATETABLET;ORAL200MGDiscontinued
ANDA084100 - LILLY
CRYSTODIGINDIGITOXININJECTABLE;INJECTION0.2MG/MLDiscontinued
ANDA080884 - LILLY
DELTALINERGOCALCIFEROLCAPSULE;ORAL50,000 IUDiscontinued
ANDA080883 - LILLY
ALPHALINVITAMIN A PALMITATECAPSULE;ORALEQ 50,000 UNITS BASEDiscontinued
ANDA080855 - LILLY
BETALIN 12CYANOCOBALAMININJECTABLE;INJECTION1MG/MLDiscontinued
BETALIN 12CYANOCOBALAMININJECTABLE;INJECTION0.1MG/MLDiscontinued
ANDA080854 - LILLY
HEXA-BETALINPYRIDOXINE HYDROCHLORIDEINJECTABLE;INJECTION100MG/MLDiscontinued
ANDA080853 - LILLY
BETALIN STHIAMINE HYDROCHLORIDEINJECTABLE;INJECTION100MG/MLDiscontinued
ANDA080256 - LILLY
METHYLTESTOSTERONEMETHYLTESTOSTERONETABLET;BUCCAL, SUBLINGUAL10MGDiscontinued
METHYLTESTOSTERONEMETHYLTESTOSTERONETABLET;BUCCAL, SUBLINGUAL25MGDiscontinued
ANDA080254 - LILLY
TESTOSTERONE PROPIONATETESTOSTERONE PROPIONATEINJECTABLE;INJECTION50MG/MLDiscontinued
ANDA062745 - LILLY
KEFLETCEPHALEXINTABLET;ORALEQ 500MG BASEDiscontinued
KEFLETCEPHALEXINTABLET;ORALEQ 250MG BASEDiscontinued
ANDA062739 - LILLY
TAZIDIME IN PLASTIC CONTAINERCEFTAZIDIMEINJECTABLE;INJECTION1GM/VIALDiscontinued
TAZIDIME IN PLASTIC CONTAINERCEFTAZIDIMEINJECTABLE;INJECTION2GM/VIALDiscontinued
ANDA062707 - LILLY
NEBCINTOBRAMYCIN SULFATEINJECTABLE;INJECTIONEQ 10MG BASE/MLDiscontinued
ANDA062655 - LILLY
TAZIDIMECEFTAZIDIMEINJECTABLE;INJECTION2GM/VIALDiscontinued
TAZIDIMECEFTAZIDIMEINJECTABLE;INJECTION1GM/VIALDiscontinued
ANDA062592 - LILLY
KEFUROXCEFUROXIME SODIUMINJECTABLE;INTRAVENOUSEQ 750MG BASE/VIALDiscontinued
KEFUROXCEFUROXIME SODIUMINJECTABLE;INJECTIONEQ 1.5GM BASE/VIALDiscontinued
ANDA062590 - LILLY
KEFUROX IN PLASTIC CONTAINERCEFUROXIME SODIUMINJECTABLE;INJECTIONEQ 1.5GM BASE/VIALDiscontinued
KEFUROX IN PLASTIC CONTAINERCEFUROXIME SODIUMINJECTABLE;INTRAVENOUSEQ 750MG BASE/VIALDiscontinued
ANDA062565 - LILLY
AMPICILLIN SODIUMAMPICILLIN SODIUMINJECTABLE;INJECTIONEQ 500MG BASE/VIALDiscontinued
AMPICILLIN SODIUMAMPICILLIN SODIUMINJECTABLE;INJECTIONEQ 1GM BASE/VIALDiscontinued
AMPICILLIN SODIUMAMPICILLIN SODIUMINJECTABLE;INJECTIONEQ 2GM BASE/VIALDiscontinued
ANDA062560 - LILLY
MANDOLCEFAMANDOLE NAFATEINJECTABLE;INJECTIONEQ 1GM BASE/VIALDiscontinued
MANDOLCEFAMANDOLE NAFATEINJECTABLE;INJECTIONEQ 2GM BASE/VIALDiscontinued
ANDA062557 - LILLY
KEFZOLCEFAZOLIN SODIUMINJECTABLE;INJECTIONEQ 1GM BASE/VIALDiscontinued
KEFZOLCEFAZOLIN SODIUMINJECTABLE;INJECTIONEQ 500MG BASE/VIALDiscontinued
ANDA062549 - LILLY
KEFLIN IN PLASTIC CONTAINERCEPHALOTHIN SODIUMINJECTABLE;INJECTIONEQ 1GM BASE/VIALDiscontinued
KEFLIN IN PLASTIC CONTAINERCEPHALOTHIN SODIUMINJECTABLE;INJECTIONEQ 2GM BASE/VIALDiscontinued
ANDA062177 - DISTA
ERYTHROMYCIN ETHYLSUCCINATEERYTHROMYCIN ETHYLSUCCINATESUSPENSION;ORALEQ 200MG BASE/5MLDiscontinued
ERYTHROMYCIN ETHYLSUCCINATEERYTHROMYCIN ETHYLSUCCINATESUSPENSION;ORALEQ 400MG BASE/5MLDiscontinued
ANDA062008 - LILLY
NEBCINTOBRAMYCIN SULFATEINJECTABLE;INJECTIONEQ 40MG BASE/MLDiscontinued
NEBCINTOBRAMYCIN SULFATEINJECTABLE;INJECTIONEQ 10MG BASE/MLDiscontinued
ANDA061910 - DISTA
ILOTYCINERYTHROMYCINTABLET, DELAYED RELEASE;ORAL250MGDiscontinued
ANDA061897 - LILLY
ILOSONEERYTHROMYCIN ESTOLATECAPSULE;ORALEQ 125MG BASEDiscontinued
ILOSONEERYTHROMYCIN ESTOLATECAPSULE;ORALEQ 250MG BASEDiscontinued
ANDA061896 - LILLY
ILOSONEERYTHROMYCIN ESTOLATETABLET;ORALEQ 500MG BASEDiscontinued
ANDA061895 - DISTA
ILOSONEERYTHROMYCIN ESTOLATETABLET, CHEWABLE;ORALEQ 125MG BASEDiscontinued
ILOSONEERYTHROMYCIN ESTOLATETABLET, CHEWABLE;ORALEQ 250MG BASEDiscontinued
ANDA061894 - LILLY
ILOSONEERYTHROMYCIN ESTOLATESUSPENSION;ORALEQ 125MG BASE/5MLDiscontinued
ILOSONEERYTHROMYCIN ESTOLATESUSPENSION;ORALEQ 250MG BASE/5MLDiscontinued
ILOSONEERYTHROMYCIN ESTOLATESUSPENSION/DROPS;ORALEQ 100MG BASE/MLDiscontinued
ANDA061893 - DISTA
ILOSONEERYTHROMYCIN ESTOLATEFOR SUSPENSION;ORALEQ 125MG BASE/5MLDiscontinued
ANDA060687 - LILLY
BACITRACINBACITRACINOINTMENT;OPHTHALMIC500 UNITS/GMDiscontinued
ANDA060601 - LILLY
PENICILLIN G POTASSIUMPENICILLIN G POTASSIUMINJECTABLE;INJECTION20,000,000 UNITS/VIALDiscontinued
ANDA060404 - LILLY
STREPTOMYCIN SULFATESTREPTOMYCIN SULFATEINJECTABLE;INJECTIONEQ 1GM BASE/2MLDiscontinued
ANDA060403 - LILLY
PENICILLIN G POTASSIUMPENICILLIN G POTASSIUMTABLET;ORAL250,000 UNITSDiscontinued
ANDA060385 - LILLY
NEOMYCIN SULFATENEOMYCIN SULFATETABLET;ORAL500MGDiscontinued
ANDA060384 - LILLY
PENICILLIN G POTASSIUMPENICILLIN G POTASSIUMINJECTABLE;INJECTION5,000,000 UNITS/VIALDiscontinued
PENICILLIN G POTASSIUMPENICILLIN G POTASSIUMINJECTABLE;INJECTION1,000,000 UNITS/VIALDiscontinued
PENICILLIN G POTASSIUMPENICILLIN G POTASSIUMINJECTABLE;INJECTION500,000 UNITS/VIALDiscontinued
PENICILLIN G POTASSIUMPENICILLIN G POTASSIUMINJECTABLE;INJECTION200,000 UNITS/VIALDiscontinued
PENICILLIN G POTASSIUMPENICILLIN G POTASSIUMINJECTABLE;INJECTION20,000,000 UNITS/VIALDiscontinued
ANDA060107 - LILLY
STREPTOMYCIN SULFATESTREPTOMYCIN SULFATEINJECTABLE;INJECTIONEQ 1GM BASE/VIALDiscontinued
STREPTOMYCIN SULFATESTREPTOMYCIN SULFATEINJECTABLE;INJECTIONEQ 5GM BASE/VIALDiscontinued
ANDA060093 - LILLY
DURACILLIN A.S.PENICILLIN G PROCAINEINJECTABLE;INJECTION300,000 UNITS/MLDiscontinued
ANDA060004 - LILLY
V-CILLIN KPENICILLIN V POTASSIUMFOR SOLUTION;ORALEQ 250MG BASE/5MLDiscontinued
V-CILLIN KPENICILLIN V POTASSIUMFOR SOLUTION;ORALEQ 125MG BASE/5MLDiscontinued
ANDA060003 - LILLY
V-CILLIN KPENICILLIN V POTASSIUMTABLET;ORALEQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
V-CILLIN KPENICILLIN V POTASSIUMTABLET;ORALEQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
V-CILLIN KPENICILLIN V POTASSIUMTABLET;ORALEQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
ANDA060002 - LILLY
V-CILLINPENICILLIN VFOR SUSPENSION;ORAL125MG/0.6MLDiscontinued
NDA050678 - LILLY RES LABS
DYNABACDIRITHROMYCINTABLET, DELAYED RELEASE;ORAL250MGDiscontinued
NDA050673 - LILLY
CECLOR CDCEFACLORTABLET, EXTENDED RELEASE;ORALEQ 375MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
CECLOR CDCEFACLORTABLET, EXTENDED RELEASE;ORALEQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA050614 - LILLY
KEFTABCEPHALEXIN HYDROCHLORIDETABLET;ORALEQ 250MG BASEDiscontinued
KEFTABCEPHALEXIN HYDROCHLORIDETABLET;ORALEQ 500MG BASEDiscontinued
KEFTABCEPHALEXIN HYDROCHLORIDETABLET;ORALEQ 333MG BASEDiscontinued
NDA050599 - LILLY
ILOSONE SULFAERYTHROMYCIN ESTOLATE; SULFISOXAZOLE ACETYLSUSPENSION;ORALEQ 125MG BASE/5ML;EQ 600MG BASE/5MLDiscontinued
NDA050550 - LILLY
MOXAMMOXALACTAM DISODIUMINJECTABLE;INJECTIONEQ 10GM BASE/VIALDiscontinued
MOXAMMOXALACTAM DISODIUMINJECTABLE;INJECTIONEQ 2GM BASE/VIALDiscontinued
MOXAMMOXALACTAM DISODIUMINJECTABLE;INJECTIONEQ 1GM BASE/VIALDiscontinued
MOXAMMOXALACTAM DISODIUMINJECTABLE;INJECTIONEQ 250MG BASE/VIALDiscontinued
MOXAMMOXALACTAM DISODIUMINJECTABLE;INJECTIONEQ 500MG BASE/VIALDiscontinued
NDA050532 - LILLY
ERYTHROMYCINERYTHROMYCINSOLUTION;TOPICAL2%Discontinued
NDA050522 - LILLY
CECLORCEFACLORFOR SUSPENSION;ORALEQ 125MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
CECLORCEFACLORFOR SUSPENSION;ORALEQ 250MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA050521 - LILLY
CECLORCEFACLORCAPSULE;ORALEQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
CECLORCEFACLORCAPSULE;ORALEQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA050519 - LILLY
NEBCINTOBRAMYCIN SULFATEINJECTABLE;INJECTIONEQ 1.2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA050504 - LILLY
MANDOLCEFAMANDOLE NAFATEINJECTABLE;INJECTIONEQ 10GM BASE/VIALDiscontinued
MANDOLCEFAMANDOLE NAFATEINJECTABLE;INJECTIONEQ 500MG BASE/VIALDiscontinued
MANDOLCEFAMANDOLE NAFATEINJECTABLE;INJECTIONEQ 2GM BASE/VIALDiscontinued
MANDOLCEFAMANDOLE NAFATEINJECTABLE;INJECTIONEQ 1GM BASE/VIALDiscontinued
NDA050482 - LILLY
KEFLINCEPHALOTHIN SODIUMINJECTABLE;INJECTIONEQ 20GM BASE/VIALDiscontinued
KEFLINCEPHALOTHIN SODIUMINJECTABLE;INJECTIONEQ 4GM BASE/VIALDiscontinued
KEFLINCEPHALOTHIN SODIUMINJECTABLE;INJECTIONEQ 2GM BASE/VIALDiscontinued
KEFLINCEPHALOTHIN SODIUMINJECTABLE;INJECTIONEQ 1GM BASE/VIALDiscontinued
NDA050477 - LILLY
NEBCINTOBRAMYCIN SULFATEINJECTABLE;INJECTIONEQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA050440 - LILLY
KEFLETCEPHALEXINTABLET;ORALEQ 250MG BASEDiscontinued
KEFLETCEPHALEXINTABLET;ORALEQ 500MG BASEDiscontinued
KEFLETCEPHALEXINTABLET;ORALEQ 1GM BASEDiscontinued
NDA050370 - DISTA
ILOTYCIN GLUCEPTATEERYTHROMYCIN GLUCEPTATEINJECTABLE;INJECTIONEQ 1GM BASE/VIALDiscontinued
ILOTYCIN GLUCEPTATEERYTHROMYCIN GLUCEPTATEINJECTABLE;INJECTIONEQ 250MG BASE/VIALDiscontinued
ILOTYCIN GLUCEPTATEERYTHROMYCIN GLUCEPTATEINJECTABLE;INJECTIONEQ 500MG BASE/VIALDiscontinued
NDA050368 - DISTA
ILOTYCINERYTHROMYCINOINTMENT;OPHTHALMIC0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA050346 - LILLY
CORDRAN NFLURANDRENOLIDE; NEOMYCIN SULFATECREAM;TOPICAL0.05%;EQ 3.5MG BASE/GMDiscontinued
NDA050345 - LILLY
CORDRAN NFLURANDRENOLIDE; NEOMYCIN SULFATEOINTMENT;TOPICAL0.05%;EQ 3.5MG BASE/GMDiscontinued
NDA050219 - LILLY
KAFOCINCEPHALOGLYCINCAPSULE;ORAL250MGDiscontinued
NDA050010 - LILLY
ILOSONEERYTHROMYCIN ESTOLATESUSPENSION;ORALEQ 125MG BASE/5MLDiscontinued
ILOSONEERYTHROMYCIN ESTOLATESUSPENSION;ORALEQ 250MG BASE/5MLDiscontinued
NDA022516 - LILLY
CYMBALTADULOXETINE HYDROCHLORIDECAPSULE, DELAYED REL PELLETS; ORALEQ 20MG BASEPrescription
CYMBALTADULOXETINE HYDROCHLORIDECAPSULE, DELAYED REL PELLETS; ORALEQ 30MG BASEPrescription
CYMBALTADULOXETINE HYDROCHLORIDECAPSULE, DELAYED REL PELLETS; ORALEQ 60MG BASEPrescription
NDA022504 - ELI LILLY AND CO
AXIRONTESTOSTERONESOLUTION, METERED;TRANSDERMAL30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA022332 - ELI LILLY CO
ADCIRCATADALAFILTABLET;ORAL20MGPrescription
NDA022148 - LILLY
CYMBALTADULOXETINE HYDROCHLORIDECAPSULE, DELAYED REL PELLETS; ORALEQ 30MG BASEPrescription
CYMBALTADULOXETINE HYDROCHLORIDECAPSULE, DELAYED REL PELLETS; ORALEQ 60MG BASEPrescription
CYMBALTADULOXETINE HYDROCHLORIDECAPSULE, DELAYED REL PELLETS; ORALEQ 20MG BASEPrescription
NDA022042 - LILLY
EVISTARALOXIFENE HYDROCHLORIDETABLET; ORAL60MGPrescription
NDA021733 - LILLY
CYMBALTADULOXETINE HYDROCHLORIDECAPSULE, DELAYED REL PELLETS; ORALEQ 20MG BASEPrescription
CYMBALTADULOXETINE HYDROCHLORIDECAPSULE, DELAYED REL PELLETS; ORALEQ 30MG BASEPrescription
CYMBALTADULOXETINE HYDROCHLORIDECAPSULE, DELAYED REL PELLETS; ORALEQ 60MG BASEPrescription
NDA021677 - LILLY
ALIMTAPEMETREXEDINJECTABLE; INJECTION500MGPrescription
NDA021520 - LILLY
SYMBYAXFLUOXETINE HYDROCHLORIDE; OLANZAPINECAPSULE;ORALEQ 25MG BASE;EQ 3MG BASEPrescription
SYMBYAXFLUOXETINE HYDROCHLORIDE; OLANZAPINECAPSULE;ORALEQ 25MG BASE;EQ 12MG BASEPrescription
SYMBYAXFLUOXETINE HYDROCHLORIDE; OLANZAPINECAPSULE;ORALEQ 50MG BASE;EQ 12MG BASEPrescription
SYMBYAXFLUOXETINE HYDROCHLORIDE; OLANZAPINECAPSULE;ORALEQ 25MG BASE;EQ 6MG BASEPrescription
SYMBYAXFLUOXETINE HYDROCHLORIDE; OLANZAPINECAPSULE;ORALEQ 50MG BASE;EQ 6MG BASEPrescription
NDA021462 - LILLY
ALIMTAPEMETREXED DISODIUMPOWDER;INTRAVENOUSEQ 100MG BASE/VIALPrescription
ALIMTAPEMETREXED DISODIUMPOWDER;INTRAVENOUSEQ 500MG BASE/VIALPrescription
NDA021427 - LILLY
CYMBALTADULOXETINE HYDROCHLORIDECAPSULE, DELAYED REL PELLETS;ORALEQ 20MG BASEPrescription
CYMBALTADULOXETINE HYDROCHLORIDECAPSULE, DELAYED REL PELLETS;ORALEQ 30MG BASEPrescription
CYMBALTADULOXETINE HYDROCHLORIDECAPSULE, DELAYED REL PELLETS;ORALEQ 60MG BASEPrescription
NDA021411 - LILLY
STRATTERAATOMOXETINE HYDROCHLORIDECAPSULE;ORALEQ 10MG BASEPrescription
STRATTERAATOMOXETINE HYDROCHLORIDECAPSULE;ORALEQ 25MG BASEPrescription
STRATTERAATOMOXETINE HYDROCHLORIDECAPSULE;ORALEQ 40MG BASEPrescription
STRATTERAATOMOXETINE HYDROCHLORIDECAPSULE;ORALEQ 60MG BASEPrescription
STRATTERAATOMOXETINE HYDROCHLORIDECAPSULE;ORALEQ 80MG BASEPrescription
STRATTERAATOMOXETINE HYDROCHLORIDECAPSULE;ORALEQ 100MG BASEPrescription
STRATTERAATOMOXETINE HYDROCHLORIDECAPSULE;ORALEQ 18MG BASEPrescription
STRATTERAATOMOXETINE HYDROCHLORIDECAPSULE;ORALEQ 5MG BASEDiscontinued
NDA021368 - LILLY
CIALISTADALAFILTABLET;ORAL10MGPrescription
CIALISTADALAFILTABLET;ORAL20MGPrescription
CIALISTADALAFILTABLET;ORAL2.5MGPrescription
CIALISTADALAFILTABLET;ORAL5MGPrescription
NDA021318 - LILLY
FORTEOTERIPARATIDESOLUTION;SUBCUTANEOUS0.75MG/3ML (0.25MG/ML)Discontinued
FORTEOTERIPARATIDESOLUTION;SUBCUTANEOUS0.6MG/2.4ML (0.25MG/ML)Prescription
NDA021235 - LILLY
PROZAC WEEKLYFLUOXETINE HYDROCHLORIDECAPSULE, DELAYED REL PELLETS;ORALEQ 90MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
BLA021018 - LILLY
HUMALOG MIX 50/50INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANTINJECTABLE;INJECTION50 UNITS/ML;50 UNITS/MLPrescription
HUMALOG MIX 50/50 PENINSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANTINJECTABLE;INJECTION50 UNITS/ML;50 UNITS/MLDiscontinued
HUMALOG MIX 50/50 KWIKPENINSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANTINJECTABLE;INJECTION50 UNITS/ML;50 UNITS/MLPrescription
BLA021017 - LILLY
HUMALOG MIX 75/25 KWIKPENINSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANTINJECTABLE;INJECTION75 UNITS/ML;25 UNITS/MLPrescription
HUMALOG MIX 75/25 PENINSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANTINJECTABLE;INJECTION75 UNITS/ML;25 UNITS/MLDiscontinued
HUMALOG MIX 75/25INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANTINJECTABLE;INJECTION75 UNITS/ML;25 UNITS/MLPrescription
NDA020974 - LILLY
PROZACFLUOXETINE HYDROCHLORIDETABLET;ORALEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
PROZACFLUOXETINE HYDROCHLORIDETABLET;ORALEQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA020928 - LILLY
GLUCAGONGLUCAGONINJECTABLE;INJECTION1MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA020815 - LILLY
EVISTARALOXIFENE HYDROCHLORIDETABLET;ORAL60MGPrescription
BLA020563 - LILLY
HUMALOGINSULIN LISPRO RECOMBINANTINJECTABLE;INJECTION100 UNITS/MLPrescription
HUMALOG PENINSULIN LISPRO RECOMBINANTINJECTABLE;INJECTION100 UNITS/MLDiscontinued
HUMALOG KWIKPENINSULIN LISPRO RECOMBINANTINJECTABLE;INJECTION100 UNITS/MLPrescription
HUMALOG KWIKPENINSULIN LISPRO RECOMBINANTINJECTABLE;INJECTION200UNITS/MLPrescription
HUMALOG TEMPO PENINSULIN LISPRO RECOMBINANTINJECTABLE;INJECTION100UNITS/MLPrescription
NDA020509 - LILLY
GEMZARGEMCITABINE HYDROCHLORIDEINJECTABLE;INJECTIONEQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
GEMZARGEMCITABINE HYDROCHLORIDEINJECTABLE;INJECTIONEQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA020101 - LILLY
PROZACFLUOXETINE HYDROCHLORIDESOLUTION;ORALEQ 20MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
BLA019717 - LILLY
HUMULIN 70/30INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMANINJECTABLE;INJECTION30 UNITS/ML;70 UNITS/MLOver-the-counter
HUMULIN 70/30 PENINSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMANINJECTABLE;INJECTION30 UNITS/ML;70 UNITS/MLOver-the-counter
NDA019693 - LILLY
DECABIDINDECAINIDE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 100MG BASEDiscontinued
DECABIDINDECAINIDE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 50MG BASEDiscontinued
DECABIDINDECAINIDE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 75MG BASEDiscontinued
BLA019640 - LILLY
HUMATROPESOMATROPININJECTABLE;INJECTION12MG/VIALPrescription
HUMATROPESOMATROPININJECTABLE;INJECTION24MG/VIALPrescription
HUMATROPESOMATROPININJECTABLE;INJECTION6MG/VIALPrescription
HUMATROPESOMATROPININJECTABLE;INJECTION5MG/VIALPrescription
HUMATROPESOMATROPININJECTABLE;INJECTION2MG/VIALDiscontinued
NDA018936 - ELI LILLY AND CO
SARAFEMFLUOXETINE HYDROCHLORIDECAPSULE;ORALEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
SARAFEMFLUOXETINE HYDROCHLORIDECAPSULE;ORALEQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
PROZACFLUOXETINE HYDROCHLORIDECAPSULE;ORALEQ 20MG BASEPrescription
PROZACFLUOXETINE HYDROCHLORIDECAPSULE;ORALEQ 40MG BASEPrescription
PROZACFLUOXETINE HYDROCHLORIDECAPSULE;ORALEQ 60MG BASEDiscontinued
PROZACFLUOXETINE HYDROCHLORIDECAPSULE;ORALEQ 10MG BASEPrescription
BLA018781 - LILLY
HUMULIN NINSULIN SUSP ISOPHANE RECOMBINANT HUMANINJECTABLE;INJECTION100 UNITS/MLOver-the-counter
BLA018780 - LILLY
HUMULIN RINSULIN RECOMBINANT HUMANINJECTABLE;INJECTION100 UNITS/MLOver-the-counter
HUMULIN R KWIKPENINSULIN HUMANSOLUTION;SUBCUTANEOUS1500 UNITS/3ML (500 UNITS/ML)Prescription
HUMULIN RINSULIN HUMANSOLUTION;SUBCUTANEOUS10000 UNITS/20ML (500 UNITS/ML)Prescription
HUMULIN R PENINSULIN RECOMBINANT HUMANINJECTABLE;INJECTION100 UNITS/MLOver-the-counter
NDA018067 - LILLY
CINOBACCINOXACINCAPSULE;ORAL250MGDiscontinued
CINOBACCINOXACINCAPSULE;ORAL500MGDiscontinued
NDA017820 - LILLY
DOBUTREXDOBUTAMINE HYDROCHLORIDEINJECTABLE;INJECTIONEQ 12.5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA017710 - DISTA
NALFONFENOPROFEN CALCIUMTABLET;ORALEQ 600MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA014684 - LILLY
AVENTYL HYDROCHLORIDENORTRIPTYLINE HYDROCHLORIDECAPSULE;ORALEQ 10MG BASEDiscontinued
AVENTYL HYDROCHLORIDENORTRIPTYLINE HYDROCHLORIDECAPSULE;ORALEQ 25MG BASEDiscontinued
NDA014103 - LILLY
ONCOVINVINCRISTINE SULFATEINJECTABLE;INJECTION1MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
ONCOVINVINCRISTINE SULFATEINJECTABLE;INJECTION5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
ONCOVINVINCRISTINE SULFATEINJECTABLE;INJECTION1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA013378 - LILLY
DYMELORACETOHEXAMIDETABLET;ORAL500MGDiscontinued
DYMELORACETOHEXAMIDETABLET;ORAL250MGDiscontinued
NDA013157 - LILLY
ANHYDRONCYCLOTHIAZIDETABLET;ORAL2MGDiscontinued
NDA012936 - LILLY
DROLBANDROMOSTANOLONE PROPIONATEINJECTABLE;INJECTION50MG/MLDiscontinued
NDA012928 - LILLY
NOVRADLEVOPROPOXYPHENE NAPSYLATE ANHYDROUSSUSPENSION;ORALEQ 50MG BASE/5MLDiscontinued
NOVRADLEVOPROPOXYPHENE NAPSYLATE ANHYDROUSCAPSULE;ORALEQ 100MG BASEDiscontinued
NOVRADLEVOPROPOXYPHENE NAPSYLATE ANHYDROUSCAPSULE;ORALEQ 50MG BASEDiscontinued
NDA012772 - LILLY
HALDRONEPARAMETHASONE ACETATETABLET;ORAL1MGDiscontinued
HALDRONEPARAMETHASONE ACETATETABLET;ORAL2MGDiscontinued
NDA012665 - LILLY
VELBANVINBLASTINE SULFATEINJECTABLE;INJECTION10MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA012122 - LILLY
GLUCAGONGLUCAGON HYDROCHLORIDEINJECTABLE;INJECTIONEQ 1MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
GLUCAGONGLUCAGON HYDROCHLORIDEINJECTABLE;INJECTIONEQ 10MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA010012 - LILLY
SANDRILRESERPINEINJECTABLE;INJECTION2.5MG/MLDiscontinued
NDA009750 - DISTA
VALMIDETHINAMATECAPSULE;ORAL500MGDiscontinued
NDA009376 - LILLY
SANDRILRESERPINETABLET;ORAL0.25MGDiscontinued
SANDRILRESERPINETABLET;ORAL0.1MGDiscontinued
NDA009344 - LILLY
HISTALOGBETAZOLE HYDROCHLORIDEINJECTABLE;INJECTION50MG/MLDiscontinued
NDA009238 - LILLY
PROGESTERONEPROGESTERONEINJECTABLE;INJECTION50MG/MLDiscontinued
PROGESTERONEPROGESTERONEINJECTABLE;INJECTION25MG/MLDiscontinued
NDA008951 - LILLY
PAGITANECYCRIMINE HYDROCHLORIDETABLET;ORAL1.25MGDiscontinued
PAGITANECYCRIMINE HYDROCHLORIDETABLET;ORAL2.5MGDiscontinued
NDA008869 - LILLY
DICURIN PROCAINEPROCAINE MERETHOXYLLINE; THEOPHYLLINEINJECTABLE;INJECTION100MG/ML;50MG/MLDiscontinued
NDA008499 - LILLY
ISONIAZIDISONIAZIDTABLET;ORAL100MGDiscontinued
ISONIAZIDISONIAZIDTABLET;ORAL300MGDiscontinued
NDA007865 - LILLY
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEINJECTABLE;INJECTION2MEQ/MLDiscontinued
NDA007529 - LILLY
QUINIDINE GLUCONATEQUINIDINE GLUCONATEINJECTABLE;INJECTION80MG/MLDiscontinued
NDA007392 - LILLY
SECONAL SODIUMSECOBARBITAL SODIUMINJECTABLE;INJECTION50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA007245 - LILLY
AEROLONEISOPROTERENOL HYDROCHLORIDESOLUTION;INHALATION0.25%Discontinued
NDA006632 - LILLY
METUBINE IODIDEMETOCURINE IODIDEINJECTABLE;INJECTION2MG/MLDiscontinued
NDA006470 - LILLY
CALCIUM GLUCEPTATECALCIUM GLUCEPTATEINJECTABLE;INJECTIONEQ 90MG CALCIUM/5MLDiscontinued
NDA006460 - LILLY
PROTAMINE SULFATEPROTAMINE SULFATEINJECTABLE;INJECTION10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA006325 - LILLY
TUBOCURARINE CHLORIDETUBOCURARINE CHLORIDEINJECTABLE;INJECTION3MG/MLDiscontinued
NDA006317 - LILLY
SULFONAMIDES DUPLEXSULFADIAZINE; SULFAMERAZINESUSPENSION;ORAL250MG/5ML;250MG/5MLDiscontinued
NEOTRIZINETRISULFAPYRIMIDINES (SULFADIAZINE;SULFAMERAZINE;SULFAMETHAZINE)TABLET;ORAL167MG;167MG;167MGDiscontinued
NEOTRIZINETRISULFAPYRIMIDINES (SULFADIAZINE;SULFAMERAZINE;SULFAMETHAZINE)SUSPENSION;ORAL167MG/5ML;167MG/5ML;167MG/5MLDiscontinued
NDA006213 - LILLY
PROPYLTHIOURACILPROPYLTHIOURACILTABLET;ORAL50MGDiscontinued
NDA006135 - LILLY
FOLIC ACIDFOLIC ACIDTABLET;ORAL1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA005725 - LILLY
KAPPADIONEMENADIOL SODIUM DIPHOSPHATEINJECTABLE;INJECTION10MG/MLDiscontinued
NDA005521 - LILLY
HEPARIN SODIUMHEPARIN SODIUMINJECTABLE;INJECTION1,000 UNITS/MLDiscontinued
HEPARIN SODIUMHEPARIN SODIUMINJECTABLE;INJECTION10,000 UNITS/MLDiscontinued
HEPARIN SODIUMHEPARIN SODIUMINJECTABLE;INJECTION20,000 UNITS/MLDiscontinued
NDA005509 - LILLY
DICUMAROLDICUMAROLCAPSULE;ORAL50MGDiscontinued
DICUMAROLDICUMAROLCAPSULE;ORAL25MGDiscontinued
NDA004122 - LILLY
SULFADIAZINESULFADIAZINETABLET;ORAL500MGDiscontinued
NDA004041 - LILLY
DIETHYLSTILBESTROLDIETHYLSTILBESTROLTABLET;ORAL0.1MGDiscontinued
DIETHYLSTILBESTROLDIETHYLSTILBESTROLTABLET;ORAL0.5MGDiscontinued
DIETHYLSTILBESTROLDIETHYLSTILBESTROLTABLET;ORAL1MGDiscontinued
DIETHYLSTILBESTROLDIETHYLSTILBESTROLTABLET;ORAL5MGDiscontinued
NDA004040 - LILLY
DIETHYLSTILBESTROLDIETHYLSTILBESTROLSUPPOSITORY;VAGINAL0.1MGDiscontinued
DIETHYLSTILBESTROLDIETHYLSTILBESTROLSUPPOSITORY;VAGINAL0.5MGDiscontinued
NDA004039 - LILLY
DIETHYLSTILBESTROLDIETHYLSTILBESTROLTABLET, DELAYED RELEASE;ORAL0.1MGDiscontinued
DIETHYLSTILBESTROLDIETHYLSTILBESTROLTABLET, DELAYED RELEASE;ORAL0.5MGDiscontinued
DIETHYLSTILBESTROLDIETHYLSTILBESTROLTABLET, DELAYED RELEASE;ORAL1MGDiscontinued
DIETHYLSTILBESTROLDIETHYLSTILBESTROLTABLET, DELAYED RELEASE;ORAL0.25MGDiscontinued
DIETHYLSTILBESTROLDIETHYLSTILBESTROLTABLET, DELAYED RELEASE;ORAL5MGDiscontinued
NDA002139 - LILLY
MENADIONEMENADIONETABLET;ORAL5MGDiscontinued
NDA000734 - LILLY
HISTAMINE PHOSPHATEHISTAMINE PHOSPHATEINJECTABLE;INJECTIONEQ 1MG BASE/MLDiscontinued
HISTAMINE PHOSPHATEHISTAMINE PHOSPHATEINJECTABLE;INJECTIONEQ 0.2MG BASE/MLDiscontinued
HISTAMINE PHOSPHATEHISTAMINE PHOSPHATEINJECTABLE;INJECTIONEQ 0.1MG BASE/MLDiscontinued
NDA000159 - LILLY
SULFAPYRIDINESULFAPYRIDINETABLET;ORAL500MGDiscontinued