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Week of Dec 1, 2025

32

Dec 2, 2025approval256d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: ELITE LABS INC. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Dec 2, 2025approval256d agoTEVIMBRA (TISLELIZUMAB-JSGR) — FDA approvalBeOne Medicines Ltd.

Sponsor: BEIGENE. Form: INJECTION. Route: SOLUTION

full page →fda approvals ↗

Dec 2, 2025approval256d agoOLANZAPINE — FDA approvalTorrent Pharma Inc

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

full page →fda approvals ↗

Dec 2, 2025approval256d agoJAYPIRCA (PIRTOBRUTINIB) — FDA approvalEli Lilly and Co

Sponsor: LOXO ONCOL. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 2, 2025approval256d agoPROPOFOL — FDA approvalBika Biotechnology Guanzhou Co Ltd

Sponsor: NANJING KING FRIEND. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Dec 2, 2025approval256d agoLEVETIRACETAM — FDA approvalLEVETIRACETAM

Sponsor: KNACK. Form: INJECTABLE. Route: INTRAVENOUS

full page →LEVETIRACETAM →fda approvals ↗

Dec 2, 2025approval256d agoSITAGLIPTIN AND METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) — FDA approvalmetformin hydrochloride ER

Sponsor: SANDOZ. Form: TABLET. Route: ORAL

full page →metformin hydrochloride ER →fda approvals ↗

Dec 3, 2025approval255d agoERTUGLIFLOZIN — FDA approvalERTUGLIFLOZIN

Sponsor: AUROBINDO PHARMA LTD. Form: TABLET. Route: ORAL

full page →ERTUGLIFLOZIN →fda approvals ↗

Dec 3, 2025approval255d agoMACITENTAN — FDA approvalJOHNSON & JOHNSON

Sponsor: SEASONS BIOTECH. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 3, 2025approval255d agoMACITENTAN — FDA approvalMACITENTAN

Sponsor: MYLAN. Form: TABLET. Route: ORAL

full page →MACITENTAN →fda approvals ↗

Dec 3, 2025approval255d agoOLANZAPINE — FDA approvalolanzapine ODT

Sponsor: TORRENT. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

full page →olanzapine ODT →fda approvals ↗

Dec 4, 2025approval254d agoEPLERENONE — FDA approvalEPLERENONE

Sponsor: RISING. Form: TABLET. Route: ORAL

full page →EPLERENONE →fda approvals ↗

Dec 4, 2025approval254d agoTOPIRAMATE — FDA approvaltopiramate ER

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

full page →topiramate ER →fda approvals ↗

Dec 5, 2025approval253d agoONTRUZANT (TRASTUZUMAB-DTTB) — FDA approvalONTRUZANT

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

full page →ONTRUZANT →fda approvals ↗

Dec 5, 2025approval253d agoOXYCODONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗

Dec 5, 2025approval253d agoOXYCODONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗

Dec 5, 2025approval253d agoOXYCODONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗

Dec 5, 2025approval253d agoOXYCODONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗

Dec 5, 2025approval253d agoOXYCODONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗

Dec 5, 2025approval253d agoOXYCODONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗

Dec 5, 2025approval253d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: GRANULES. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Dec 5, 2025approval253d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalEon Labs Inc

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

full page →fda approvals ↗

Dec 5, 2025approval253d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: CHARTWELL. Form: SOLUTION. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Dec 5, 2025approval253d agoOXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗

Dec 5, 2025approval253d agoRIFADIN (RIFAMPIN) — FDA approvalRIFADIN

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

full page →RIFADIN →fda approvals ↗

Dec 5, 2025approval253d agoRIFATER (ISONIAZID) — FDA approvalRIFATER

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

full page →RIFATER →fda approvals ↗

Dec 5, 2025approval253d agoILLUCCIX (GALLIUM GA-68 GOZETOTIDE) — FDA approvalILLUCCIX

Sponsor: TELIX. Form: POWDER. Route: INTRAVENOUS

full page →ILLUCCIX →fda approvals ↗

Dec 5, 2025approval253d agoRIFADIN (RIFAMPIN) — FDA approvalRIFADIN

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

full page →RIFADIN →fda approvals ↗

Dec 5, 2025approval253d agoETICOVO (ETANERCEPT-YKRO) — FDA approvalETICOVO

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

full page →ETICOVO →fda approvals ↗

Dec 5, 2025approval253d agoAMANTADINE HYDROCHLORIDE — FDA approvalShinkei Therapeutics LLC

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

full page →fda approvals ↗

Dec 5, 2025approval253d agoACETAMINOPHEN — FDA approvalIGC Pharma, Inc.

Sponsor: CAPLIN. Form: SOLUTION. Route: INTRAVENOUS

full page →fda approvals ↗

Dec 5, 2025approval253d 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

18

Dec 8, 2025approval250d 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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