Calendar

Week of Mar 27, 2023

Mar 27, 2023approval1255d agoHALOPERIDOL DECANOATE — FDA approvalZydus Therapeutics Inc

Sponsor: ZYDUS PHARMS. Form: INJECTABLE. Route: INJECTION

Mar 27, 2023approval1255d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalIGC Pharma, Inc.

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

full page →fda approvals ↗

Mar 28, 2023approval1254d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

Sponsor: MERCK SHARP DOHME. Form: SOLUTION. Route: INTRAVENOUS

full page →pembrolizumab →fda approvals ↗

Mar 29, 2023approval1253d agoNARCAN (NALOXONE HYDROCHLORIDE) — FDA approvalEmergent Devices Inc

Sponsor: EMERGENT. Form: SPRAY, METERED. Route: NASAL

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Mar 29, 2023approval1253d agoVEKLURY (REMDESIVIR) — FDA approvalremdesivir

Sponsor: GILEAD SCIENCES INC. Form: SOLUTION. Route: INTRAVENOUS

full page →remdesivir →fda approvals ↗

Mar 30, 2023approval1252d agoLINAGLIPTIN AND METFORMIN HYDROCHLORIDE (LINAGLIPTIN) — FDA approvalZydus Therapeutics Inc

Sponsor: ZYDUS PHARMS. Form: TABLET. Route: ORAL

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Mar 30, 2023approval1252d agoSIMPONI (GOLIMUMAB) — FDA approvalJanssen Biotech Inc

Sponsor: CENTOCOR ORTHO BIOTECH INC. Form: INJECTABLE. Route: INJECTION

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Mar 30, 2023approval1252d agoORGOVYX (RELUGOLIX) — FDA approvalrelugolix

Sponsor: SUMITOMO PHARMA AM. Form: TABLET. Route: ORAL

full page →relugolix →fda approvals ↗

Mar 30, 2023approval1252d agoZIPRASIDONE HYDROCHLORIDE — FDA approvalLupin Ltd

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

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Mar 30, 2023approval1252d agoZIPRASIDONE HYDROCHLORIDE — FDA approvalLupin Ltd

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

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Mar 30, 2023approval1252d agoZIPRASIDONE HYDROCHLORIDE — FDA approvalLupin Ltd

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

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Mar 31, 2023approval1251d agoPREZCOBIX (COBICISTAT) — FDA approvalGILEAD SCIENCES, INC.

Sponsor: JANSSEN PRODS. Form: TABLET. Route: ORAL

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Mar 31, 2023approval1251d agoYUSIMRY (ADALIMUMAB-AQVH) — FDA approvalYUSIMRY

Sponsor: COHERUS BIOSCIENCES INC. Form: INJECTABLE. Route: INJECTION

full page →YUSIMRY →fda approvals ↗

Week of Apr 3, 2023

Apr 3, 2023approval1248d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

Sponsor: MERCK SHARP DOHME. Form: SOLUTION. Route: INTRAVENOUS

full page →pembrolizumab →fda approvals ↗

Apr 3, 2023approval

Week of Apr 10, 2023

Apr 10, 2023approval1241d agoNISOLDIPINE — FDA approvalPrasco LLC

Sponsor: AMTA. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Apr 10, 2023approval

Week of Apr 17, 2023

Apr 17, 2023approval1234d agoVALACYCLOVIR HYDROCHLORIDE — FDA approvalVALACYCLOVIR HYDROCHLORIDE

Sponsor: JUBILANT GENERICS. Form: TABLET. Route: ORAL

full page →VALACYCLOVIR HYDROCHLORIDE →fda approvals ↗

Apr 17, 2023approval

Week of Apr 24, 2023

Apr 24, 2023approval1227d agoZEGERID OTC (OMEPRAZOLE) — FDA approvalCovis Pharmaceuticals Inc (Inactive)

Sponsor: RILEY CONSUMER. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Apr 25, 2023approval

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