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calendar

18,993 catalysts · 18,987 approval · 5,347 phase readout · 5,000 device 510k · 4,728 grant · 2,603 8k filing · 2,000 device pma

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2026-08-03: 4 catalysts2026-08-04: 13 catalysts2026-08-05: 17 catalysts2026-08-06: 11 catalysts2026-08-07: 1 catalyst2026-08-08: 0 catalysts2026-08-09: 0 catalysts2026-08-10: 2 catalysts2026-08-11: 1 catalyst2026-08-12: 1 catalyst2026-08-13: 1 catalyst2026-08-14: 0 catalysts2026-08-15: 0 catalysts2026-08-16: 0 catalysts2026-08-17: 0 catalysts2026-08-18: 1 catalyst2026-08-19: 0 catalysts2026-08-20: 0 catalysts2026-08-21: 0 catalysts2026-08-22: 0 catalysts2026-08-23: 0 catalysts2026-08-24: 0 catalysts2026-08-25: 0 catalysts2026-08-26: 0 catalysts2026-08-27: 0 catalysts2026-08-28: 0 catalysts2026-08-29: 0 catalysts2026-08-30: 0 catalysts2026-08-31: 0 catalysts2026-09-01: 1 catalyst2026-09-02: 0 catalysts2026-09-03: 0 catalysts2026-09-04: 0 catalysts2026-09-05: 0 catalysts2026-09-06: 0 catalysts2026-09-07: 0 catalysts2026-09-08: 0 catalysts2026-09-09: 0 catalysts2026-09-10: 0 catalysts2026-09-11: 0 catalysts2026-09-12: 0 catalysts2026-09-13: 0 catalysts2026-09-14: 0 catalysts2026-09-15: 0 catalysts2026-09-16: 0 catalysts2026-09-17: 0 catalysts2026-09-18: 0 catalysts2026-09-19: 0 catalysts2026-09-20: 0 catalysts2026-09-21: 0 catalysts2026-09-22: 0 catalysts2026-09-23: 0 catalysts2026-09-24: 0 catalysts2026-09-25: 0 catalysts2026-09-26: 0 catalysts2026-09-27: 0 catalysts2026-09-28: 0 catalysts2026-09-29: 0 catalysts2026-09-30: 0 catalysts2026-10-01: 0 catalysts2026-10-02: 0 catalysts2026-10-03: 0 catalysts2026-10-04: 0 catalysts2026-10-05: 0 catalysts2026-10-06: 0 catalysts2026-10-07: 0 catalysts2026-10-08: 0 catalysts2026-10-09: 0 catalysts2026-10-10: 0 catalysts2026-10-11: 0 catalysts2026-10-12: 0 catalysts2026-10-13: 0 catalysts2026-10-14: 0 catalysts2026-10-15: 0 catalysts2026-10-16: 0 catalysts2026-10-17: 0 catalysts2026-10-18: 0 catalysts2026-10-19: 0 catalysts2026-10-20: 1 catalyst2026-10-21: 1 catalyst2026-10-22: 2 catalysts2026-10-23: 0 catalysts2026-10-24: 0 catalysts2026-10-25: 0 catalysts2026-10-26: 0 catalysts2026-10-27: 2 catalysts2026-10-28: 1 catalyst2026-10-29: 3 catalysts2026-10-30: 0 catalysts2026-10-31: 0 catalysts2026-11-01: 0 catalysts
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  • approval18,987
  • phase readout5,347
  • device 510k5,000
  • grant4,728
  • 8k filing2,603
  • device pma2,000
  • device recall
2,000
  • recall1,126
  • device adverse event1,000
  • pdufa347
  • therapy area
    • Ophthalmology5

    Week of Dec 26, 2011

    7
    ›Dec 27, 2011approval5333d agoPAROXETINE HYDROCHLORIDE — FDA approvalPAROXETINE HYDROCHLORIDE

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

    full page →PAROXETINE HYDROCHLORIDE →fda approvals ↗
    ›Dec 27, 2011approval5333d agoPAROXETINE HYDROCHLORIDE — FDA approvalPAROXETINE HYDROCHLORIDE

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

    full page →PAROXETINE HYDROCHLORIDE →fda approvals ↗
    ›Dec 28, 2011approval5332d agoCLOZAPINE — FDA approvalTeva Pharmaceuticals USA Inc

    Sponsor: IVAX SUB TEVA PHARMS. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Dec 28, 2011approval5332d agoCLOZAPINE — FDA approvalTeva Pharmaceuticals USA Inc

    Sponsor: IVAX SUB TEVA PHARMS. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Dec 28, 2011approval5332d agoACTIQ (FENTANYL CITRATE) — FDA approvalTeva Pharmaceuticals USA Inc

    Sponsor: CEPHALON. Form: TROCHE/LOZENGE. Route: TRANSMUCOSAL

    full page →fda approvals ↗
    ›Dec 28, 2011approval5332d agoFENTORA (FENTANYL CITRATE) — FDA approvalTeva Pharmaceuticals USA Inc

    Sponsor: CEPHALON. Form: TABLET. Route: BUCCAL, SUBLINGUAL

    full page →fda approvals ↗
    ›Dec 30, 2011approval5330d agoTRAMADOL HYDROCHLORIDE — FDA approvalTrigen Laboratories Inc

    Sponsor: SUN PHARM. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗

    Week of Jan 9, 2012

    4
    ›Jan 11, 2012approval5318d agoSYNAREL (NAFARELIN ACETATE) — FDA approvalnafarelin acetate

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

    full page →nafarelin acetate →fda approvals ↗
    ›Jan 11, 2012approval

    Week of Jan 16, 2012

    4
    ›Jan 17, 2012approval5312d agoALFUZOSIN HYDROCHLORIDE — FDA approvalInvaGen Pharmaceuticals Inc

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

    full page →fda approvals ↗
    ›Jan 19, 2012approval

    Week of Jan 23, 2012

    7
    ›Jan 23, 2012approval5306d agoMORPHINE SULFATE — FDA approvalKapanol

    Sponsor: HIKMA. Form: SOLUTION. Route: ORAL

    full page →Kapanol →fda approvals ↗
    ›Jan 23, 2012approval

    Week of Jan 30, 2012

    11
    ›Jan 30, 2012approval5299d agoAMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN) — FDA approvalamoxicillin

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

    full page →amoxicillin →fda approvals ↗
    ›Jan 30, 2012approval

    Week of Feb 6, 2012

    4
    ›Feb 6, 2012approval5292d agoFOSAMAX (ALENDRONATE SODIUM) — FDA approvalALENDRONATE SODIUM

    Sponsor: ORGANON. Form: TABLET. Route: ORAL

    full page →ALENDRONATE SODIUM →fda approvals ↗
    ›Feb 7, 2012approval

    Week of Feb 13, 2012

    5
    ›Feb 13, 2012approval5285d agoONDANSETRON HYDROCHLORIDE — FDA approvalondansetron hydrochloride CR

    Sponsor: DR REDDYS LABS LTD. Form: TABLET. Route: ORAL

    full page →ondansetron hydrochloride CR →fda approvals ↗
    ›Feb 13, 2012approval

    Week of Feb 20, 2012

    1
    ›Feb 24, 2012approval5274d agoOZURDEX (DEXAMETHASONE) — FDA approvaldexamethasone LA

    Sponsor: ABBVIE. Form: IMPLANT. Route: INTRAVITREAL

    full page →dexamethasone LA →fda approvals ↗

    Week of Feb 27, 2012

    7
    ›Feb 27, 2012approval5271d agoLAMOTRIGINE — FDA approvalZydus Pharmaceuticals USA Inc

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

    full page →fda approvals ↗
    ›Feb 27, 2012approval
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    5318d ago
    CIPROFLOXACIN HYDROCHLORIDE — FDA approvalCIPROFLOXACIN HYDROCHLORIDE

    Sponsor: CHARTWELL. Form: TABLET. Route: ORAL

    full page →CIPROFLOXACIN HYDROCHLORIDE →fda approvals ↗
    ›Jan 12, 2012approval5317d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

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

    full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗
    ›Jan 12, 2012approval5317d agoTHALLOUS CHLORIDE TL 201 (THALLOUS CHLORIDE TL-201) — FDA approval

    Sponsor: CURIUM. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    5310d ago
    MYORISAN (ISOTRETINOIN) — FDA approvalSun Pharmaceutical Industries Ltd

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

    full page →fda approvals ↗
    ›Jan 20, 2012approval5309d agoSOJOURN (SEVOFLURANE) — FDA approvalSEVOFLURANE

    Sponsor: PIRAMAL CRITICAL. Form: LIQUID. Route: INHALATION

    full page →SEVOFLURANE →fda approvals ↗
    ›Jan 20, 2012approval5309d agoTAMSULOSIN HYDROCHLORIDE — FDA approvalSynthon Pharmaceuticals Inc (Inactive)

    Sponsor: PHARMOBEDIENT. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    5306d ago
    MORPHINE SULFATE — FDA approvalKapanol

    Sponsor: HIKMA. Form: TABLET. Route: ORAL

    full page →Kapanol →fda approvals ↗
    ›Jan 23, 2012approval5306d agoVINCRISTINE SULFATE PFS (VINCRISTINE SULFATE) — FDA approvalVINCRISTINE SULFATE PFS

    Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

    full page →VINCRISTINE SULFATE PFS →fda approvals ↗
    ›Jan 24, 2012approval5305d agoCARBAMAZEPINE — FDA approvalcarbamazepine ER

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

    full page →carbamazepine ER →fda approvals ↗
    ›Jan 25, 2012approval5304d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

    Sponsor: GENUS. Form: SOLUTION. Route: ORAL

    full page →fda approvals ↗
    ›Jan 25, 2012approval5304d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

    Sponsor: GENUS LIFESCIENCES. Form: SOLUTION. Route: ORAL

    full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗
    ›Jan 26, 2012approval5303d agoMETFORMIN HYDROCHLORIDE — FDA approvalCenter for Biomedical Research for Neurodegenetive Diseases

    Sponsor: GRANULES INDIA. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    5299d ago
    RISPERIDONE — FDA approvalAmneal Pharmaceuticals, Inc.

    Sponsor: AMNEAL PHARMS. Form: SOLUTION. Route: ORAL

    full page →fda approvals ↗
    ›Jan 31, 2012approval5298d agoLAMOTRIGINE — FDA approvalLAMOTRIGINE

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

    full page →LAMOTRIGINE →fda approvals ↗
    ›Jan 31, 2012approval5298d agoKALYDECO (IVACAFTOR) — FDA approvalVertex, Inc.

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

    full page →fda approvals ↗
    ›Jan 31, 2012approval5298d agoGLEEVEC (IMATINIB MESYLATE) — FDA approvalImatinib Mesylate Shilpa

    Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

    full page →Imatinib Mesylate Shilpa →fda approvals ↗
    ›Jan 31, 2012approval5298d agoSOJOURN (SEVOFLURANE) — FDA approvalSEVOFLURANE

    Sponsor: PIRAMAL CRITICAL. Form: LIQUID. Route: INHALATION

    full page →SEVOFLURANE →fda approvals ↗
    ›Jan 31, 2012approval5298d agoVYVANSE (LISDEXAMFETAMINE DIMESYLATE) — FDA approvalTakeda Pharmaceuticals USA Inc

    Sponsor: TAKEDA PHARMS USA. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Feb 1, 2012approval5297d agoCOSOPT PF (DORZOLAMIDE HYDROCHLORIDE) — FDA approvalCosopt

    Sponsor: THEA PHARMA. Form: SOLUTION/DROPS. Route: OPHTHALMIC

    full page →Cosopt →fda approvals ↗
    ›Feb 1, 2012approval5297d agoIMPLANON (ETONOGESTREL) — FDA approvaletonogestrel CR

    Sponsor: ORGANON. Form: IMPLANT. Route: IMPLANTATION

    full page →etonogestrel CR →fda approvals ↗
    ›Feb 3, 2012approval5295d agoTIZANIDINE HYDROCHLORIDE — FDA approvalTIZANIDINE HYDROCHLORIDE

    Sponsor: APOTEX INC. Form: CAPSULE. Route: ORAL

    full page →TIZANIDINE HYDROCHLORIDE →fda approvals ↗
    ›Feb 4, 2012approval5294d agoDILTIAZEM HYDROCHLORIDE — FDA approvalBausch Health US LLC

    Sponsor: PH HEALTH. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗
    5291d ago
    ADDERALL XR 10 (AMPHETAMINE ASPARTATE) — FDA approvalTakeda Pharmaceuticals USA Inc

    Sponsor: TAKEDA PHARMS USA. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗
    ›Feb 9, 2012approval5289d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

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

    full page →BUPROPION HYDROCHLORIDE →fda approvals ↗
    ›Feb 10, 2012approval5288d agoZIOPTAN (TAFLUPROST) — FDA approvaltafluprost

    Sponsor: THEA PHARMA. Form: SOLUTION/DROPS. Route: OPHTHALMIC

    full page →tafluprost →fda approvals ↗
    5285d ago
    FENTANYL CITRATE — FDA approvalEffentora

    Sponsor: HIKMA. Form: INJECTABLE. Route: INJECTION

    full page →Effentora →fda approvals ↗
    ›Feb 16, 2012approval5282d agoONDANSETRON — FDA approvalondansetron ODT

    Sponsor: AUROBINDO PHARMA. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

    full page →ondansetron ODT →fda approvals ↗
    ›Feb 16, 2012approval5282d agoONDANSETRON — FDA approvalondansetron ODT

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

    full page →ondansetron ODT →fda approvals ↗
    ›Feb 17, 2012approval5281d agoLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalAlembic Pharmaceuticals Inc

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

    full page →fda approvals ↗
    5271d ago
    LAMOTRIGINE — FDA approvalZydus Pharmaceuticals USA Inc

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

    full page →fda approvals ↗
    ›Feb 28, 2012approval5270d agoLAMOTRIGINE — FDA approvalZydus Pharmaceuticals USA Inc

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

    full page →fda approvals ↗
    ›Mar 1, 2012approval5268d agoIMITREX (SUMATRIPTAN) — FDA approvalSUMATRIPTAN SUCCINATE

    Sponsor: GLAXOSMITHKLINE. Form: SPRAY. Route: NASAL

    full page →SUMATRIPTAN SUCCINATE →fda approvals ↗
    ›Mar 1, 2012approval5268d agoIMITREX (SUMATRIPTAN) — FDA approvalSUMATRIPTAN SUCCINATE

    Sponsor: GLAXOSMITHKLINE. Form: SPRAY. Route: NASAL

    full page →SUMATRIPTAN SUCCINATE →fda approvals ↗
    ›Mar 1, 2012approval5268d agoIMITREX (SUMATRIPTAN SUCCINATE) — FDA approvalSUMATRIPTAN SUCCINATE

    Sponsor: GLAXOSMITHKLINE. Form: TABLET. Route: ORAL

    full page →SUMATRIPTAN SUCCINATE →fda approvals ↗
    ›Mar 1, 2012approval5268d agoIMITREX (SUMATRIPTAN SUCCINATE) — FDA approvalSUMATRIPTAN SUCCINATE

    Sponsor: GLAXOSMITHKLINE. Form: TABLET. Route: ORAL

    full page →SUMATRIPTAN SUCCINATE →fda approvals ↗
    $PFE25.01+0.40%
    $IGC0.2670+0.41%
    $RDY11.85+0.17%
    $OGN13.550.00%
    $ABBV250.94-2.51%
    $AMRX18.32-0.97%
    $VERX12.91+2.46%
    $OGN13.550.00%
    $NVS156.15-1.45%