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calendar

18,993 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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soonest latest type sponsor alpha

type: filing×type: approval×clear all

type

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

Ophthalmology5

Week of Sep 22, 2025

›Sep 26, 2025approval337d agoTACROLIMUS — FDA approvaltacrolimus ER

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

full page →tacrolimus ER →fda approvals ↗

›Sep 26, 2025approval337d agoXPOVIO (SELINEXOR) — FDA approvalselinexor

Sponsor: KARYOPHARM THERAPS. Form: TABLET. Route: ORAL

full page →selinexor →fda approvals ↗

›Sep 26, 2025approval337d agoVORICONAZOLE — FDA approvalVORICONAZOLE

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

full page →VORICONAZOLE →fda approvals ↗

›Sep 26, 2025approval337d agoACETYLCYSTEINE — FDA approvalACETYLCYSTEINE

Sponsor: SOMERSET THERAPS LLC. Form: SOLUTION. Route: INHALATION, ORAL

full page →ACETYLCYSTEINE →fda approvals ↗

›Sep 26, 2025approval337d agoDICLOFENAC SODIUM — FDA approvalHisamitsu Pharmaceutical Co Inc

Sponsor: ENCUBE. Form: GEL. Route: TOPICAL

full page →fda approvals ↗

›Sep 26, 2025approval337d agoAMPHETAMINE SULFATE — FDA approvalAurolife Pharma LLC

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

full page →fda approvals ↗

›Sep 28, 2025approval335d agoESTRADIOL AND PROGESTERONE (ESTRADIOL) — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗

›Sep 28, 2025approval335d agoSULFAMETHOPRIM (SULFAMETHOXAZOLE) — FDA approval

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

full page →fda approvals ↗

›Sep 28, 2025approval335d agoSULFAMETHOPRIM (SULFAMETHOXAZOLE) — FDA approval

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

full page →fda approvals ↗

Week of Sep 29, 2025

›Sep 29, 2025approval334d agoLAMOTRIGINE — FDA approvalZydus Pharmaceuticals USA Inc

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

full page →fda approvals ↗

›Sep 29, 2025approval

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page 332 of 380

334d ago

LAMOTRIGINE — FDA approvalLAMOTRIGINE

Sponsor: ZYDUS PHARMS USA INC. Form: TABLET, FOR SUSPENSION. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗

›Sep 29, 2025approval334d agoCALCIUM CHLORIDE 10% (CALCIUM CHLORIDE) — FDA approvalSquare Pharmaceuticals PLC

Sponsor: SQUARE PHARMS PLC. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

›Sep 29, 2025approval334d agoDESIPRAMINE HYDROCHLORIDE — FDA approvalDESIPRAMINE HYDROCHLORIDE

Sponsor: ALEMBIC. Form: TABLET. Route: ORAL

full page →DESIPRAMINE HYDROCHLORIDE →fda approvals ↗

›Sep 29, 2025approval334d agoTIZANIDINE HYDROCHLORIDE — FDA approvalTIZANIDINE HYDROCHLORIDE

Sponsor: INGENUS PHARMS LLC. Form: CAPSULE. Route: ORAL

full page →TIZANIDINE HYDROCHLORIDE →fda approvals ↗

›Sep 29, 2025approval334d agoIFOSFAMIDE — FDA approvalIFOSFAMIDE

Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: INJECTION

full page →IFOSFAMIDE →fda approvals ↗

›Sep 30, 2025approval333d agoDOXYCYCLINE HYCLATE — FDA approvalDOXYCYCLINE HYCLATE

Sponsor: AMNEAL. Form: TABLET. Route: ORAL

full page →DOXYCYCLINE HYCLATE →fda approvals ↗

›Sep 30, 2025approval333d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

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

full page →tramadol hydrochloride ER →fda approvals ↗

›Sep 30, 2025approval333d agoMIFEPREX (MIFEPRISTONE) — FDA approvalCORCEPT THERAPEUTICS INC

Sponsor: DANCO LABS LLC. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Sep 30, 2025approval333d agoQULIPTA (ATOGEPANT) — FDA approvalatogepant

Sponsor: ABBVIE. Form: TABLET. Route: ORAL

full page →atogepant →fda approvals ↗

›Sep 30, 2025approval333d agoMIFEPRISTONE — FDA approvalMIFEPRISTONE

Sponsor: GENBIOPRO. Form: TABLET. Route: ORAL

full page →MIFEPRISTONE →fda approvals ↗

›Sep 30, 2025approval333d agoOLANZAPINE — FDA approvalZydus Therapeutics Inc

Sponsor: ZYDUS PHARMS. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

full page →fda approvals ↗

›Sep 30, 2025approval333d agoLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalMacleods Pharmaceuticals Ltd

Sponsor: IPCA LABS LTD. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Sep 30, 2025approval333d agoIRBESARTAN — FDA approvalIRBESARTAN

Sponsor: HETERO LABS LTD V. Form: TABLET. Route: ORAL

full page →IRBESARTAN →fda approvals ↗

›Sep 30, 2025approval333d agoVORICONAZOLE — FDA approvalGreenstone LLC

Sponsor: NOVEL LABS INC. Form: FOR SUSPENSION. Route: ORAL

full page →fda approvals ↗

›Sep 30, 2025approval333d agoOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

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

full page →ALDACTAZIDE →fda approvals ↗

›Sep 30, 2025approval333d agoTEGRETOL-XR (CARBAMAZEPINE) — FDA approvalcarbamazepine ER

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

full page →carbamazepine ER →fda approvals ↗

›Sep 30, 2025approval333d agoFENOFIBRIC ACID (CHOLINE FENOFIBRATE) — FDA approvalcholine fenofibrate

Sponsor: ACTAVIS ELIZABETH. Form: CAPSULE, DELAYED RELEASE. Route: ORAL

full page →choline fenofibrate →fda approvals ↗

›Sep 30, 2025approval333d agoPREGABALIN — FDA approvalPREGABALIN

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

full page →PREGABALIN →fda approvals ↗

›Sep 30, 2025approval333d agoTEGRETOL (CARBAMAZEPINE) — FDA approvalcarbamazepine ER

Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

full page →carbamazepine ER →fda approvals ↗

›Sep 30, 2025approval333d agoRHAPSIDO (REMIBRUTINIB) — FDA approvalremibrutinib

Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

full page →remibrutinib →fda approvals ↗

›Sep 30, 2025approval333d agoMIFEPRISTONE — FDA approvalMIFEPRISTONE

Sponsor: EVITA SOLUTIONS. Form: TABLET. Route: ORAL

full page →MIFEPRISTONE →fda approvals ↗

›Sep 30, 2025approval333d agoTIZANIDINE HYDROCHLORIDE — FDA approvalRiconpharma LLC

Sponsor: ALKEM LABS LTD. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

›Sep 30, 2025approval333d agoVORICONAZOLE — FDA approvalVORICONAZOLE

Sponsor: MEITHEAL. Form: POWDER. Route: INTRAVENOUS

full page →VORICONAZOLE →fda approvals ↗