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calendar

18,994 catalysts · 18,987 approval · 7,208 phase readout · 5,000 device 510k · 4,728 grant · 3,603 8k filing · 2,000 device pma

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type: pdufa×type: approval×clear all
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  • approval18,987
  • phase readout7,208
  • device 510k5,000
  • grant4,728
  • 8k filing3,603
  • device pma2,000
  • device recall
2,000
  • recall1,126
  • device adverse event1,000
  • earnings585
  • therapy area
    • Dermatology1
    • Infectious Disease1

    Week of Dec 29, 2025

    19
    ›Dec 31, 2025approval242d agoDICLOFENAC SODIUM — FDA approvalDICLOFENAC SODIUM

    Sponsor: AUROBINDO PHARMA USA. Form: TABLET, DELAYED RELEASE. Route: ORAL

    full page →DICLOFENAC SODIUM →fda approvals ↗
    ›Dec 31, 2025approval242d agoOXYMORPHONE HYDROCHLORIDE — FDA approvalOXYMORPHONE HYDROCHLORIDE

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

    full page →OXYMORPHONE HYDROCHLORIDE →fda approvals ↗
    ›Dec 31, 2025approval242d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

    Sponsor: STRIDES PHARMA INTL. Form: TABLET. Route: ORAL

    full page →acetaminophen ER →fda approvals ↗
    ›Dec 31, 2025approval242d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

    full page →acetaminophen ER →fda approvals ↗
    ›Dec 31, 2025approval242d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

    full page →acetaminophen ER →fda approvals ↗
    ›Dec 31, 2025approval242d agoOXYCODONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

    Sponsor: PHARMOBEDIENT. Form: SOLUTION. Route: ORAL

    full page →fda approvals ↗
    ›Dec 31, 2025approval242d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

    Sponsor: UPSHER SMITH LABS. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Dec 31, 2025approval242d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

    Sponsor: UPSHER SMITH LABS. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Dec 31, 2025approval242d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

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

    full page →tramadol hydrochloride ER →fda approvals ↗
    ›Dec 31, 2025approval242d agoSELENIOUS ACID — FDA approvalSELENIOUS ACID

    Sponsor: RK PHARMA. Form: SOLUTION. Route: INTRAVENOUS

    full page →SELENIOUS ACID →fda approvals ↗
    ›Dec 31, 2025approval242d agoPONSTEL (MEFENAMIC ACID) — FDA approvalAvion Pharmaceuticals LLC

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

    full page →fda approvals ↗
    ›Dec 31, 2025approval242d agoLAMOTRIGINE — FDA approvalLAMOTRIGINE

    Sponsor: AUROBINDO PHARMA. Form: TABLET, FOR SUSPENSION. Route: ORAL

    full page →LAMOTRIGINE →fda approvals ↗
    ›Dec 31, 2025approval242d agoTRAMADOL HYDROCHLORIDE — FDA approvalSenores Pharmaceuticals Inc

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

    full page →fda approvals ↗
    ›Dec 31, 2025approval242d agoTRAMADOL HYDROCHLORIDE — FDA approvalSenores Pharmaceuticals Inc

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

    full page →fda approvals ↗
    ›Dec 31, 2025approval242d agoATORVASTATIN CALCIUM — FDA approvalViatris Inc

    Sponsor: UMEDICA. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Jan 2, 2026approval240d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

    Sponsor: RUBICON RESEARCH. Form: TABLET. Route: SUBLINGUAL

    full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
    ›Jan 2, 2026approval240d agoACETAMINOPHEN AND IBUPROFEN (ACETAMINOPHEN) — FDA approvalPERRIGO Co plc

    Sponsor: TARO. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Jan 2, 2026approval240d agoEXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) — FDA approvalEXTENDED PHENYTOIN SODIUM

    Sponsor: MANKIND PHARMA. Form: CAPSULE. Route: ORAL

    full page →EXTENDED PHENYTOIN SODIUM →fda approvals ↗
    ›Jan 2, 2026approval240d agoHYDROCODONE BITARTRATE AND ASPIRIN (ASPIRIN) — FDA approvalPurdue Pharma LP

    Sponsor: LGM PHARMA. Form: TABLET. Route: ORAL

    full page →fda approvals ↗

    Week of Jan 5, 2026

    31
    ›Jan 5, 2026approval237d agoLORAZEPAM — FDA approvallorazepam ER

    Sponsor: RISING. Form: TABLET. Route: ORAL

    full page →lorazepam ER →fda approvals ↗
    ›Jan 5, 2026approval
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    page 357 of 380
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    237d ago
    AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN) — FDA approvalamoxicillin

    Sponsor: SANDOZ INC. Form: FOR SUSPENSION. Route: ORAL

    full page →amoxicillin →fda approvals ↗
    ›Jan 5, 2026approval237d agoSUCRALFATE — FDA approvalSUCRALFATE

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

    full page →SUCRALFATE →fda approvals ↗
    ›Jan 5, 2026approval237d agoHALOPERIDOL DECANOATE — FDA approvalZydus Therapeutics Inc

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

    full page →fda approvals ↗
    ›Jan 5, 2026approval237d agoOXYMORPHONE HYDROCHLORIDE — FDA approvalOXYMORPHONE HYDROCHLORIDE

    Sponsor: ACTAVIS ELIZABETH. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →OXYMORPHONE HYDROCHLORIDE →fda approvals ↗
    ›Jan 5, 2026approval237d agoCARBAMAZEPINE — FDA approvalAmneal Pharmaceuticals, Inc.

    Sponsor: AMNEAL PHARMS. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗
    ›Jan 6, 2026approval236d agoOLOPATADINE HYDROCHLORIDE — FDA approvalPataday

    Sponsor: GLAND. Form: SOLUTION/DROPS. Route: OPHTHALMIC

    full page →Pataday →fda approvals ↗
    ›Jan 6, 2026approval236d agoCIPROFLOXACIN AND DEXAMETHASONE (CIPROFLOXACIN) — FDA approvalBedford Laboratories

    Sponsor: UPSHER SMITH LABS. Form: SUSPENSION/DROPS. Route: OTIC

    full page →fda approvals ↗
    ›Jan 6, 2026approval236d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

    Sponsor: HIKMA. Form: SOLUTION. Route: ORAL

    full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗
    ›Jan 6, 2026approval236d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

    Sponsor: HIKMA. Form: SOLUTION. Route: ORAL

    full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗
    ›Jan 6, 2026approval236d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

    Sponsor: HIKMA. Form: SOLUTION. Route: ORAL

    full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗
    ›Jan 6, 2026approval236d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

    Sponsor: HIKMA. Form: SOLUTION. Route: ORAL

    full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗
    ›Jan 6, 2026approval236d agoOLANZAPINE — FDA approvalolanzapine ODT

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

    full page →olanzapine ODT →fda approvals ↗
    ›Jan 6, 2026approval236d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

    Sponsor: VISTAPHARM LLC. Form: SOLUTION. Route: ORAL

    full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗
    ›Jan 6, 2026approval236d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

    Sponsor: VISTAPHARM LLC. Form: SOLUTION. Route: ORAL

    full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗
    ›Jan 6, 2026approval236d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

    Sponsor: VISTAPHARM LLC. Form: SOLUTION. Route: ORAL

    full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗
    ›Jan 6, 2026approval236d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

    Sponsor: VISTAPHARM LLC. Form: SOLUTION. Route: ORAL

    full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗
    ›Jan 6, 2026approval236d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

    Sponsor: SANALUZ. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Jan 6, 2026approval236d agoOLANZAPINE — FDA approvalolanzapine ODT

    Sponsor: STRIDES PHARMA INTL. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

    full page →olanzapine ODT →fda approvals ↗
    ›Jan 6, 2026approval236d agoMECLIZINE HYDROCHLORIDE — FDA approvalMECLIZINE HYDROCHLORIDE

    Sponsor: RISING. Form: TABLET. Route: ORAL

    full page →MECLIZINE HYDROCHLORIDE →fda approvals ↗
    ›Jan 6, 2026approval236d agoOXYCODONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

    Sponsor: NOVEL LABS INC. Form: SOLUTION. Route: ORAL

    full page →fda approvals ↗
    ›Jan 6, 2026approval236d agoOXYCODONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

    Sponsor: NOVEL LABS INC. Form: SOLUTION. Route: ORAL

    full page →fda approvals ↗
    ›Jan 6, 2026approval236d agoOXYCODONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

    Sponsor: NOVEL LABS INC. Form: SOLUTION. Route: ORAL

    full page →fda approvals ↗
    ›Jan 6, 2026approval236d agoOXYCODONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

    Sponsor: NOVEL LABS INC. Form: SOLUTION. Route: ORAL

    full page →fda approvals ↗
    ›Jan 6, 2026approval236d agoAMONDYS 45 (CASIMERSEN) — FDA approvalcasimersen

    Sponsor: SAREPTA THERAPS INC. Form: SOLUTION. Route: INTRAVENOUS

    full page →casimersen →fda approvals ↗
    ›Jan 6, 2026approval236d agoBORTEZOMIB — FDA approvalBortezomib Pfizer

    Sponsor: GLAND. Form: POWDER. Route: INTRAVENOUS, SUBCUTANEOUS

    full page →Bortezomib Pfizer →fda approvals ↗
    ›Jan 6, 2026approval236d agoROCURONIUM BROMIDE — FDA approvalROCURONIUM BROMIDE

    Sponsor: KNACK. Form: INJECTABLE. Route: INJECTION

    full page →ROCURONIUM BROMIDE →fda approvals ↗
    ›Jan 7, 2026approval235d agoZEPBOUND (TIRZEPATIDE) — FDA approvalZEPBOUND

    Sponsor: ELI LILLY AND CO. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →ZEPBOUND →fda approvals ↗
    ›Jan 7, 2026approval235d agoMOUNJARO (TIRZEPATIDE) — FDA approvalZEPBOUND

    Sponsor: ELI LILLY AND CO. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →ZEPBOUND →fda approvals ↗
    ›Jan 7, 2026approval235d agoQUETIAPINE FUMARATE — FDA approvalquetiapine fumarate ER

    Sponsor: ACCORD HLTHCARE. Form: TABLET. Route: ORAL

    full page →quetiapine fumarate ER →fda approvals ↗
    ›Jan 7, 2026approval235d agoENOXAPARIN SODIUM (PRESERVATIVE FREE) (ENOXAPARIN SODIUM) — FDA approvalShenzhen Techdow Pharmaceutical Co Ltd

    Sponsor: HEBEI CHANGSHAN. Form: INJECTABLE. Route: SUBCUTANEOUS

    full page →fda approvals ↗
    $PRGO14.48+2.84%
    $VTRS16.34-3.26%
    $IGC0.2670+0.41%
    $AMRX17.54-2.61%
    $IGC0.2670+0.41%
    $IGC0.2670+0.41%
    $AMRX17.54-2.61%
    $AMRX17.54-2.61%
    $AMRX17.54-2.61%
    $AMRX17.54-2.61%
    $AMRX17.54-2.61%
    $SRPT20.86-3.38%
    $LLY1174.61-0.13%
    $LLY1174.61-0.13%