Calendar

Week of Mar 18, 2024

Mar 20, 2024approval875d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: HIKMA. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

Mar 20, 2024approval875d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalIGC Pharma, Inc.

Sponsor: ALKEM LABS LTD. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗

Mar 20, 2024approval875d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalIGC Pharma, Inc.

Sponsor: PHARMOBEDIENT. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗

Mar 20, 2024approval875d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: ETHYPHARM. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

Mar 20, 2024approval875d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalIGC Pharma, Inc.

Sponsor: RHODES PHARMS. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗

Mar 20, 2024approval875d agoSUBOXONE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: INDIVIOR. Form: FILM. Route: BUCCAL, SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

Mar 20, 2024approval875d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalIGC Pharma, Inc.

Sponsor: BARR. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗

Mar 20, 2024approval875d agoZUBSOLV (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalEdenbridge Pharmaceuticals LLC

Sponsor: EDENBRIDGE PHARMS. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗

Mar 20, 2024approval875d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: SPECGX LLC. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

Mar 20, 2024approval875d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: LANNETT CO INC. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

Mar 20, 2024approval875d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: AMNEAL PHARMS. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗

Mar 20, 2024approval875d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: ACTAVIS ELIZABETH. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

Mar 21, 2024approval874d agoFLUOROURACIL — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: TEVA PHARMS USA. Form: INJECTABLE. Route: INJECTION

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Mar 21, 2024approval874d agoFLUOROURACIL — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: TEVA PHARMS USA. Form: INJECTABLE. Route: INJECTION

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Mar 21, 2024approval874d agoFLUOROURACIL — FDA approvalEfudex

Sponsor: SAGENT PHARMS INC. Form: INJECTABLE. Route: INJECTION

full page →Efudex →fda approvals ↗

Mar 21, 2024approval874d agoFLUOROURACIL — FDA approvalEfudex

Sponsor: SAGENT PHARMS INC. Form: INJECTABLE. Route: INJECTION

full page →Efudex →fda approvals ↗

Mar 21, 2024approval874d agoFLUOROURACIL — FDA approvalEfudex

Sponsor: ACCORD HLTHCARE. Form: INJECTABLE. Route: INJECTION

full page →Efudex →fda approvals ↗

Mar 21, 2024approval874d agoFLUOROURACIL — FDA approvalExtrovis AG

Sponsor: EUGIA PHARMA SPECLTS. Form: INJECTABLE. Route: INJECTION

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Mar 21, 2024approval874d agoFLUOROURACIL — FDA approvalExtrovis AG

Sponsor: EUGIA PHARMA SPECLTS. Form: INJECTABLE. Route: INJECTION

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Mar 21, 2024approval874d agoFLUOROURACIL — FDA approvalEfudex

Sponsor: ACCORD HLTHCARE. Form: INJECTABLE. Route: INJECTION

full page →Efudex →fda approvals ↗

Mar 21, 2024approval874d agoFLUOROURACIL — FDA approvalExtrovis AG

Sponsor: NOVAST LABS. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Mar 21, 2024approval874d agoFLUOROURACIL — FDA approvalEfudex

Sponsor: ALEMBIC. Form: INJECTABLE. Route: INJECTION

full page →Efudex →fda approvals ↗

Mar 21, 2024approval874d agoFLUOROURACIL — FDA approvalExtrovis AG

Sponsor: NOVAST LABS. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Mar 21, 2024approval874d agoFLUOROURACIL — FDA approvalEfudex

Sponsor: ALEMBIC. Form: INJECTABLE. Route: INJECTION

full page →Efudex →fda approvals ↗

Mar 21, 2024approval874d agoFLUOROURACIL — FDA approvalEfudex

Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: INJECTION

full page →Efudex →fda approvals ↗

Mar 21, 2024approval874d agoFLUOROURACIL — FDA approvalEfudex

Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: INJECTION

full page →Efudex →fda approvals ↗

Mar 21, 2024approval874d agoFLUOROURACIL — FDA approvalEfudex

Sponsor: GLAND. Form: INJECTABLE. Route: INJECTION

full page →Efudex →fda approvals ↗

Mar 21, 2024approval874d agoFLUOROURACIL — FDA approvalEfudex

Sponsor: GLAND. Form: INJECTABLE. Route: INJECTION

full page →Efudex →fda approvals ↗

Mar 22, 2024approval873d agoNEXLETOL (BEMPEDOIC ACID) — FDA approvalbempedoic acid

Sponsor: ESPERION THERAPS INC. Form: TABLET. Route: ORAL

full page →bempedoic acid →fda approvals ↗

Mar 22, 2024approval873d agoNEXLETOL (BEMPEDOIC ACID) — FDA approvalbempedoic acid

Sponsor: ESPERION THERAPS INC. Form: TABLET. Route: ORAL

full page →bempedoic acid →fda approvals ↗

Mar 22, 2024approval873d agoNEXLIZET (BEMPEDOIC ACID) — FDA approval(bempedoic acid + ezetimibe)

Sponsor: ESPERION THERAPS INC. Form: TABLET. Route: ORAL

full page →(bempedoic acid + ezetimibe) →fda approvals ↗

Mar 22, 2024approval873d agoNEXLIZET (BEMPEDOIC ACID) — FDA approval(bempedoic acid + ezetimibe)

Sponsor: ESPERION THERAPS INC. Form: TABLET. Route: ORAL

full page →(bempedoic acid + ezetimibe) →fda approvals ↗

Mar 22, 2024approval873d agoMEPERIDINE HYDROCHLORIDE — FDA approvalMEPERIDINE HYDROCHLORIDE

Sponsor: EPIC PHARMA LLC. Form: TABLET. Route: ORAL

full page →MEPERIDINE HYDROCHLORIDE →fda approvals ↗

Mar 22, 2024approval873d agoTRAMADOL HYDROCHLORIDE — FDA approvalTrigen Laboratories Inc

Sponsor: TEVA. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Mar 22, 2024approval873d agoGAVRETO (PRALSETINIB) — FDA approvalRIGEL PHARMACEUTICALS INC

Sponsor: RIGEL PHARMS. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Mar 22, 2024approval873d agoLIVTENCITY (MARIBAVIR) — FDA approvalTakeda Pharmaceuticals USA Inc

Sponsor: TAKEDA PHARMS USA. Form: TABLET. Route: ORAL

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Mar 22, 2024approval873d agoULTOMIRIS (RAVULIZUMAB-CWVZ) — FDA approvalAlexion Pharmaceuticals Inc

Sponsor: ALEXION PHARM. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Mar 22, 2024approval873d agoULTOMIRIS (RAVULIZUMAB-CWVZ) — FDA approvalAlexion Pharmaceuticals Inc

Sponsor: ALEXION PHARM. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Week of Mar 25, 2024

Mar 26, 2024approval869d agoWINREVAIR (SOTATERCEPT-CSRK) — FDA approvalsotatercept

Sponsor: MERCK SHARP DOHME. Form: INJECTABLE. Route: INJECTION

full page →sotatercept →fda approvals ↗

Mar 27, 2024approval

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