Calendar

Week of Jan 27, 2025

Jan 29, 2025approval560d agoOLANZAPINE AND FLUOXETINE HYDROCHLORIDE (FLUOXETINE HYDROCHLORIDE) — FDA approvalEpic Pharma LLC

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

full page →fda approvals ↗

Jan 29, 2025approval560d agoOLANZAPINE AND FLUOXETINE HYDROCHLORIDE (FLUOXETINE HYDROCHLORIDE) — FDA approvalEpic Pharma LLC

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

full page →fda approvals ↗

Jan 29, 2025approval560d agoOXYMORPHONE HYDROCHLORIDE — FDA approvalOXYMORPHONE HYDROCHLORIDE

Sponsor: AVANTHI INC. Form: TABLET. Route: ORAL

full page →OXYMORPHONE HYDROCHLORIDE →fda approvals ↗

Jan 29, 2025approval560d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: ABHAI LLC. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Jan 29, 2025approval560d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: ABHAI LLC. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Jan 29, 2025approval560d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

Sponsor: ALEMBIC. Form: TABLET. Route: ORAL

full page →BUPROPION HYDROCHLORIDE →fda approvals ↗

Jan 30, 2025approval559d agoBKEMV (ECULIZUMAB-AEEB) — FDA approvaleculizumab biosimilar

Sponsor: AMGEN INC. Form: INJECTABLE. Route: INJECTION

full page →eculizumab biosimilar →fda approvals ↗

Jan 30, 2025approval559d agoTAFINLAR (DABRAFENIB MESYLATE) — FDA approvaldabrafenib mesylate ODT

Sponsor: NOVARTIS. Form: CAPSULE. Route: ORAL

full page →dabrafenib mesylate ODT →fda approvals ↗

Jan 30, 2025approval559d agoTAFINLAR (DABRAFENIB MESYLATE) — FDA approvaldabrafenib mesylate ODT

Sponsor: NOVARTIS. Form: CAPSULE. Route: ORAL

full page →dabrafenib mesylate ODT →fda approvals ↗

Jan 30, 2025approval559d agoJOURNAVX (SUZETRIGINE) — FDA approvalsuzetrigine

Sponsor: VERTEX PHARMS INC. Form: TABLET. Route: ORAL

full page →suzetrigine →fda approvals ↗

Jan 30, 2025approval559d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: SOMERSET THERAPS LLC. Form: INJECTABLE. Route: INJECTION

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

Jan 31, 2025approval558d agoSOGROYA (SOMAPACITAN-BECO) — FDA approvalsomatriptan albumin bound LA

Sponsor: NOVO NORDISK INC. Form: SOLUTION. Route: SUBCUTANEOUS

full page →somatriptan albumin bound LA →fda approvals ↗

Jan 31, 2025approval558d agoPAXLOVID (COPACKAGED) (NIRMATRELVIR) — FDA approvalPAXLOVID (COPACKAGED)

Sponsor: PFIZER. Form: TABLET. Route: ORAL

full page →PAXLOVID (COPACKAGED) →fda approvals ↗

Jan 31, 2025approval558d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

Sponsor: MACLEODS PHARMS LTD. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →tramadol hydrochloride ER →fda approvals ↗

Jan 31, 2025approval558d agoUNASYN (AMPICILLIN SODIUM) — FDA approvalUNASYN

Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

full page →UNASYN →fda approvals ↗

Jan 31, 2025approval558d agoPEPCID COMPLETE (CALCIUM CARBONATE) — FDA approvalKenvue Inc.

Sponsor: KENVUE BRANDS. Form: TABLET, CHEWABLE. Route: ORAL

full page →fda approvals ↗

Week of Feb 3, 2025

Feb 3, 2025approval555d agoVALPROIC ACID — FDA approvalCereno Scientific AB

Sponsor: CHARTWELL RX. Form: SYRUP. Route: ORAL

full page →fda approvals ↗

Feb 4, 2025approval

Week of Feb 10, 2025

Feb 10, 2025approval548d agoENZEEVU (AFLIBERCEPT-ABZV) — FDA approvalaflibercept biosimilar

Sponsor: SANDOZ INC. Form: INJECTABLE. Route: INJECTION

full page →aflibercept biosimilar →fda approvals ↗

Feb 11, 2025approval

Week of Feb 17, 2025

Feb 18, 2025approval540d agoATROPINE SULFATE — FDA approvalATROPINE SULFATE

Sponsor: ACCORD HLTHCARE. Form: SOLUTION. Route: INTRAVENOUS

full page →ATROPINE SULFATE →fda approvals ↗

Feb 18, 2025approval

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