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Week of Dec 1, 2025

21

Dec 4, 2025approval255d agoEPLERENONE — FDA approvalEPLERENONE

Sponsor: RISING. Form: TABLET. Route: ORAL

full page →EPLERENONE →fda approvals ↗

Dec 4, 2025approval255d agoTOPIRAMATE — FDA approvaltopiramate ER

Sponsor: GLENMARK PHARMS LTD. Form: TABLET. Route: ORAL

full page →topiramate ER →fda approvals ↗

Dec 5, 2025approval254d agoONTRUZANT (TRASTUZUMAB-DTTB) — FDA approvalONTRUZANT

Sponsor: SAMSUNG BIOEPIS CO LTD. Form: POWDER. Route: IV (INFUSION)

full page →ONTRUZANT →fda approvals ↗

Dec 5, 2025approval254d agoOXYCODONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: HIBROW HLTHCARE. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

Dec 5, 2025approval254d agoOXYCODONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: HIBROW HLTHCARE. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

Dec 5, 2025approval254d agoOXYCODONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: HIBROW HLTHCARE. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

Dec 5, 2025approval254d agoOXYCODONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: HIBROW HLTHCARE. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

Dec 5, 2025approval254d agoOXYCODONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: HIBROW HLTHCARE. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

Dec 5, 2025approval254d agoOXYCODONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: HIBROW HLTHCARE. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

Dec 5, 2025approval254d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: GRANULES. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Dec 5, 2025approval254d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalEon Labs Inc

Sponsor: CHARTWELL MOLECULAR. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

Dec 5, 2025approval254d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: CHARTWELL. Form: SOLUTION. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Dec 5, 2025approval254d agoOXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: PH HEALTH. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

Dec 5, 2025approval254d agoRIFADIN (RIFAMPIN) — FDA approvalRIFADIN

Sponsor: SANOFI AVENTIS US. Form: INJECTABLE. Route: INJECTION

full page →RIFADIN →fda approvals ↗

Dec 5, 2025approval254d agoRIFATER (ISONIAZID) — FDA approvalRIFATER

Sponsor: SANOFI AVENTIS US. Form: TABLET. Route: ORAL

full page →RIFATER →fda approvals ↗

Dec 5, 2025approval254d agoILLUCCIX (GALLIUM GA-68 GOZETOTIDE) — FDA approvalILLUCCIX

Sponsor: TELIX. Form: POWDER. Route: INTRAVENOUS

full page →ILLUCCIX →fda approvals ↗

Dec 5, 2025approval254d agoRIFADIN (RIFAMPIN) — FDA approvalRIFADIN

Sponsor: SANOFI AVENTIS US. Form: CAPSULE. Route: ORAL

full page →RIFADIN →fda approvals ↗

Dec 5, 2025approval254d agoETICOVO (ETANERCEPT-YKRO) — FDA approvalETICOVO

Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTABLE. Route: INJECTION

full page →ETICOVO →fda approvals ↗

Dec 5, 2025approval254d agoAMANTADINE HYDROCHLORIDE — FDA approvalShinkei Therapeutics LLC

Sponsor: SHREE HARI INTL. Form: SYRUP. Route: ORAL

full page →fda approvals ↗

Dec 5, 2025approval254d agoACETAMINOPHEN — FDA approvalIGC Pharma, Inc.

Sponsor: CAPLIN. Form: SOLUTION. Route: INTRAVENOUS

full page →fda approvals ↗

Dec 5, 2025approval254d agoARIKAYCE KIT (AMIKACIN SULFATE) — FDA approvalamikacin sulfate PR

Sponsor: INSMED INC. Form: SUSPENSION, LIPOSOMAL. Route: INHALATION

full page →amikacin sulfate PR →fda approvals ↗

Week of Dec 8, 2025

29

Dec 8, 2025approval251d agoWINREVAIR (SOTATERCEPT-CSRK) — FDA approvalsotatercept

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

full page →sotatercept →fda approvals ↗

Dec 8, 2025approval

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