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calendar

327 catalysts · 235 grant · 41 approval · 34 device recall · 11 device 510k · 6 device pma

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no tagged catalysts yet

Week of Sep 29, 2025

50
›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 ↗
›Sep 30, 2025approval333d agoCIPROFLOXACIN HYDROCHLORIDE — FDA approvalCIPROFLOXACIN HYDROCHLORIDE

Sponsor: CHARTWELL. Form: TABLET. Route: ORAL

full page →CIPROFLOXACIN HYDROCHLORIDE →fda approvals ↗
›Sep 30, 2025approval333d agoCIPROFLOXACIN HYDROCHLORIDE — FDA approvalCIPROFLOXACIN HYDROCHLORIDE

Sponsor: CHARTWELL. Form: TABLET. Route: ORAL

full page →CIPROFLOXACIN HYDROCHLORIDE →fda approvals ↗
›Sep 30, 2025approval333d agoCIPROFLOXACIN HYDROCHLORIDE — FDA approvalCIPROFLOXACIN HYDROCHLORIDE

Sponsor: CHARTWELL. Form: TABLET. Route: ORAL

full page →CIPROFLOXACIN HYDROCHLORIDE →fda approvals ↗
›Sep 30, 2025approval333d agoCIPROFLOXACIN HYDROCHLORIDE — FDA approvalCIPROFLOXACIN HYDROCHLORIDE

Sponsor: CHARTWELL. Form: TABLET. Route: ORAL

full page →CIPROFLOXACIN HYDROCHLORIDE →fda approvals ↗
›Sep 30, 2025approval333d agoCIPROFLOXACIN HYDROCHLORIDE — FDA approvalCIPROFLOXACIN HYDROCHLORIDE

Sponsor: CHARTWELL. Form: TABLET. Route: ORAL

full page →CIPROFLOXACIN HYDROCHLORIDE →fda approvals ↗
›Sep 30, 2025approval333d agoCIPROFLOXACIN HYDROCHLORIDE — FDA approvalCIPROFLOXACIN HYDROCHLORIDE

Sponsor: CHARTWELL. Form: TABLET. Route: ORAL

full page →CIPROFLOXACIN HYDROCHLORIDE →fda approvals ↗
›Sep 30, 2025approval333d agoCIPROFLOXACIN HYDROCHLORIDE — FDA approvalCIPROFLOXACIN HYDROCHLORIDE

Sponsor: CHARTWELL. Form: TABLET. Route: ORAL

full page →CIPROFLOXACIN HYDROCHLORIDE →fda approvals ↗
›Sep 30, 2025approval333d agoCIPROFLOXACIN HYDROCHLORIDE — FDA approvalCIPROFLOXACIN HYDROCHLORIDE

Sponsor: CHARTWELL. Form: TABLET. Route: ORAL

full page →CIPROFLOXACIN HYDROCHLORIDE →fda approvals ↗
›Sep 30, 2025approval333d agoLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

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

full page →ALDACTAZIDE →fda approvals ↗
›Sep 30, 2025approval333d agoPEPCID COMPLETE (CALCIUM CARBONATE) — FDA approvalKenvue Inc.

Sponsor: KENVUE BRANDS. Form: TABLET, CHEWABLE. Route: ORAL

full page →fda approvals ↗
›Sep 30, 2025approval333d agoDASATINIB — FDA approvalXspray Pharma AB

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

full page →fda approvals ↗
›Sep 30, 2025approval333d agoLEVONORGESTREL — FDA approvalPostinor

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

full page →Postinor →fda approvals ↗
›Sep 30, 2025approval333d agoMONTELUKAST SODIUM — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗
›Sep 30, 2025approval333d agoMONTELUKAST SODIUM — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗
›Sep 30, 2025approval333d agoMONTELUKAST SODIUM — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗
›Sep 30, 2025approval333d agoOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

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

full page →ALDACTAZIDE →fda approvals ↗
›Sep 30, 2025approval333d agoZIPRASIDONE HYDROCHLORIDE — FDA approvalLupin Ltd

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

full page →fda approvals ↗
›Sep 30, 2025approval333d agoLUPRON (LEUPROLIDE ACETATE) — FDA approvalInvaGen Pharmaceuticals Inc

Sponsor: ABBVIE ENDOCRINE INC. Form: SOLUTION. Route: SUBCUTANEOUS

full page →fda approvals ↗
›Sep 30, 2025approval333d agoTAMSULOSIN HYDROCHLORIDE — FDA approvalSynthon Pharmaceuticals Inc (Inactive)

Sponsor: PHARMOBEDIENT. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗
›Sep 30, 2025approval333d agoROPINIROLE HYDROCHLORIDE — FDA approvalropinirole hydrochloride ER

Sponsor: ZYDUS LIFESCIENCES. Form: TABLET. Route: ORAL

full page →ropinirole hydrochloride ER →fda approvals ↗
›Sep 30, 2025approval333d agoTEGRETOL (CARBAMAZEPINE) — FDA approvalcarbamazepine ER

Sponsor: NOVARTIS. Form: SUSPENSION. Route: ORAL

full page →carbamazepine ER →fda approvals ↗
›Sep 30, 2025approval333d agoNEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (HYDROCORTISONE) — FDA approvalET-800

Sponsor: AMNEAL. Form: SUSPENSION/DROPS. Route: OTIC

full page →ET-800 →fda approvals ↗
›Sep 30, 2025approval333d agoTOFACITINIB CITRATE — FDA approvaltofacitinib citrate ER

Sponsor: SINOTHERAPEUTICS INC. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →tofacitinib citrate ER →fda approvals ↗
›Sep 30, 2025device 510k333d agoJiangsu Bangbang Intelligent Technology Co., Ltd. — Mobility Scooter (BBR-Q40-01); Mobility Scooter (BBR-Q40-02); Mobility Scooter (BBR-Q40-03); Mobility Scooter (BBR-Q40-04); Mobility Scooter (BBR-Q40-05); Mobility Scooter (BBR-Q40-06) (510k cleared)

Product code: INI. Advisory committee: Physical Medicine. Type: Traditional

full page →fda device 510k ↗
›Sep 30, 2025device 510k333d agoMidiagnostics NV — miDiagnostics HSV-1&2 CSF Test (510k cleared)

Product code: PGH. Advisory committee: Microbiology. Type: Traditional

full page →fda device 510k ↗
›Sep 30, 2025device 510k333d agoAstrasono Technology Co., Ltd. — Astrasono A3Pro Bladder Scanner (A3Pro) (510k cleared)

Product code: IYO. Advisory committee: Radiology. Type: Traditional

full page →fda device 510k ↗
›Sep 30, 2025device 510k333d agoWright Medical Technology, Inc. (Stryker Corporation) — Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom) (510k cleared)

Product code: MQV. Advisory committee: Orthopedic. Type: Traditional

full page →fda device 510k ↗
›Sep 30, 2025device 510k333d agoFehling Instruments GmbH — Biopsy Forceps (510k cleared)

Product code: DWZ. Advisory committee: Cardiovascular. Type: Special

full page →fda device 510k ↗
›Sep 30, 2025device 510k333d agoParagon 28, Inc. — External Fixation Mini Rail System (510k cleared)

Product code: KTT. Advisory committee: Orthopedic. Type: Traditional

full page →fda device 510k ↗
›Sep 30, 2025device 510k333d agoCenters for Disease Control and Prevention — Francisella tularensis Real-time PCR assay (510k cleared)Hubei Provincial Center for Disease Control and Prevention

Product code: SGA. Advisory committee: Immunology. Type: Traditional

full page →fda device 510k ↗
›Sep 30, 2025device 510k333d agoDistalmotion SA — Dexter L6 System (510k cleared)

Product code: SDD. Advisory committee: General, Plastic Surgery. Type: Traditional

full page →fda device 510k ↗
›Sep 30, 2025device 510k333d agoArthrex, Inc. — Arthrex SpeedFLEX™ Implant (510k cleared)

Product code: OWY. Advisory committee: General, Plastic Surgery. Type: Traditional

full page →fda device 510k ↗
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$AMRX17.54-2.61%
$NVS153.81-0.54%
$AMRX17.54-2.61%
$AMRX17.54-2.61%
$NVS153.81-0.54%
$NVS153.81-0.54%
$ABBV259.04-1.47%
$KVUE19.20-0.10%
$CORT113.88-2.61%
$AMRX17.54-2.61%
$AMRX17.54-2.61%
$SIGY0.04000.00%
$NVS153.81-0.54%