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calendar

26 catalysts · 14 device 510k · 12 approval

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no tagged catalysts yet

Week of Mar 10, 2025

26
›Mar 13, 2025approval536d ago
MILNACIPRAN HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗
›Mar 13, 2025approval536d agoMILNACIPRAN HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗
›Mar 13, 2025approval536d agoACETAZOLAMIDE — FDA approvalACETAZOLAMIDE

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

full page →ACETAZOLAMIDE →fda approvals ↗
›Mar 13, 2025approval536d agoARBLI (LOSARTAN POTASSIUM) — FDA approvalLOSARTAN POTASSIUM

Sponsor: SCIENTURE. Form: SUSPENSION. Route: ORAL

full page →LOSARTAN POTASSIUM →fda approvals ↗
›Mar 13, 2025approval536d agoTYENNE (TOCILIZUMAB-AAZG) — FDA approvalTYENNE

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

full page →TYENNE →fda approvals ↗
›Mar 13, 2025approval536d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

full page →fda approvals ↗
›Mar 13, 2025approval536d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: ALVOGEN. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗
›Mar 13, 2025approval536d agoMEROPENEM — FDA approvalHQ Speciality Pharma

Sponsor: BROOKS STERISCIENCE. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗
›Mar 13, 2025approval536d agoPYZCHIVA (USTEKINUMAB-TTWE) — FDA approvalPYZCHIVA

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

full page →PYZCHIVA →fda approvals ↗
›Mar 13, 2025approval536d agoPYZCHIVA (USTEKINUMAB-TTWE) — FDA approvalPYZCHIVA

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

full page →PYZCHIVA →fda approvals ↗
›Mar 13, 2025approval536d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

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

full page →BUPROPION HYDROCHLORIDE →fda approvals ↗
›Mar 13, 2025approval536d agoBUCAPSOL (BUSPIRONE HYDROCHLORIDE) — FDA approvalBUSPIRONE HYDROCHLORIDE

Sponsor: EPIC PHARMA LLC. Form: CAPSULE. Route: ORAL

full page →BUSPIRONE HYDROCHLORIDE →fda approvals ↗
›Mar 13, 2025device 510k536d agoBioserenity Medical Devices Group — IceCap product line (510k cleared)

Product code: GXY. Advisory committee: Neurology. Type: Traditional

full page →fda device 510k ↗
›Mar 13, 2025device 510k536d agoBoston Aesthetics, Inc. — 308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z) (510k cleared)

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

full page →fda device 510k ↗
›Mar 13, 2025device 510k536d agoMedcad — MedCAD® AccuStride™ System (510k cleared)

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

full page →fda device 510k ↗
›Mar 13, 2025device 510k536d agoMY01, Inc. — MY01 Continuous Compartmental Pressure Monitor (510k cleared)

Product code: LXC. Advisory committee: Unknown. Type: Traditional

full page →fda device 510k ↗
›Mar 13, 2025device 510k536d agoZiehm Imaging GmbH — Ziehm Vision FD (510k cleared)

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

full page →fda device 510k ↗
›Mar 13, 2025device 510k536d agoSioxmed, LLC — SiOxC Cream (510k cleared)

Product code: FRO. Advisory committee: Unknown. Type: Traditional

full page →fda device 510k ↗
›Mar 13, 2025device 510k536d agoCryosurgery, Inc. — CryoFreeze Wart and Skin Tag Remover (510k cleared)

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

full page →fda device 510k ↗
›Mar 13, 2025device 510k536d agoXemis Medical Technology (Shenzhen) Co., Ltd. — Photon Therapy Apparatus (BL-10) (510k cleared)NewBay Medical Technology Co Ltd

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

full page →fda device 510k ↗
›Mar 13, 2025device 510k536d agoMaxx Orthopedics, Inc. — Freedom Total Knee System (All-poly Tibial Plate) (510k cleared)

Product code: JWH. Advisory committee: Orthopedic. Type: Special

full page →fda device 510k ↗
›Mar 13, 2025device 510k536d agoInari Medical, Inc. — FlowTriever2 Catheter (510k cleared)Mobia Medical, Inc.

Product code: QEW. Advisory committee: Cardiovascular. Type: Traditional

full page →fda device 510k ↗
›Mar 13, 2025device 510k536d agoAugmedics, Ltd. — xvision Spine system (510k cleared)

Product code: SBF. Advisory committee: Neurology. Type: Special

full page →fda device 510k ↗
›Mar 13, 2025device 510k536d agoSurgify Medical OY — Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1) (510k cleared)

Product code: HBE. Advisory committee: Neurology. Type: Special

full page →fda device 510k ↗
›Mar 13, 2025device 510k536d agoG.N.S Neolaser , Ltd. — neoLaser Laser Surgery Fibers (510k cleared)

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

full page →fda device 510k ↗
›Mar 13, 2025device 510k536d agoSpectranetics — Turbo-Elite Laser Atherectomy Catheter (510k cleared)

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

full page →fda device 510k ↗
$AMRX17.54-2.61%
$IGC0.2670+0.41%
$AMRX17.54-2.61%
$SCNX0.3314-4.08%
$MOBI