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calendar

31 catalysts · 17 approval · 14 device 510k

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Week of Nov 18, 2024

›Nov 21, 2024approval631d ago

LICART (DICLOFENAC EPOLAMINE) — FDA approvalAmzell Limited

Sponsor: IBSA INST BIO. Form: SYSTEM. Route: TOPICAL

full page →fda approvals ↗

›Nov 21, 2024approval631d agoCALDOLOR (IBUPROFEN) — FDA approvalCUMBERLAND PHARMACEUTICALS INC

Sponsor: CUMBERLAND PHARMS. Form: SOLUTION. Route: INTRAVENOUS

full page →fda approvals ↗

›Nov 21, 2024approval631d agoDICLOFENAC SODIUM — FDA approvalDICLOFENAC SODIUM

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

full page →DICLOFENAC SODIUM →fda approvals ↗

›Nov 21, 2024approval631d agoPONSTEL (MEFENAMIC ACID) — FDA approvalAvion Pharmaceuticals LLC

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

full page →fda approvals ↗

›Nov 21, 2024approval631d agoOXYCODONE HYDROCHLORIDE AND IBUPROFEN (IBUPROFEN) — FDA approvalMidol

Sponsor: ACTAVIS ELIZABETH. Form: TABLET. Route: ORAL

full page →Midol →fda approvals ↗

›Nov 21, 2024approval631d agoBUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE (ASPIRIN) — FDA approvalNovitium Pharma LLC

Sponsor: STEVENS J. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

›Nov 21, 2024approval631d agoOXYCODONE HYDROCHLORIDE AND IBUPROFEN (IBUPROFEN) — FDA approvalMidol

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

full page →Midol →fda approvals ↗

›Nov 21, 2024approval631d agoHYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE) — FDA approvalhydrocodone bitartrate ER

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

full page →hydrocodone bitartrate ER →fda approvals ↗

›Nov 21, 2024approval631d agoPERCODAN (ASPIRIN) — FDA approvalEndo Pharmaceuticals Inc

Sponsor: ENDO OPERATIONS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Nov 21, 2024approval631d agoHYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE) — FDA approvalANI PHARMACEUTICALS INC

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

full page →fda approvals ↗

›Nov 21, 2024approval631d agoBUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE (ASPIRIN) — FDA approvalBUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE

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

full page →BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE →fda approvals ↗

›Nov 21, 2024approval631d agoHYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE) — FDA approvalStrides Pharma Inc

Sponsor: ACTAVIS LABS FL INC. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Nov 21, 2024approval631d agoSYNALGOS-DC (ASPIRIN) — FDA approvalBUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE

Sponsor: SUN PHARM INDUSTRIES. Form: CAPSULE. Route: ORAL

full page →BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE →fda approvals ↗

›Nov 21, 2024approval631d agoHYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE) — FDA approvalStrides Pharma Inc

Sponsor: SUN PHARM INDS INC. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Nov 21, 2024approval631d agoHYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE) — FDA approvalStrides Pharma Inc

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

full page →fda approvals ↗

›Nov 21, 2024approval631d agoHYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE) — FDA approvalhydrocodone bitartrate ER

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

full page →hydrocodone bitartrate ER →fda approvals ↗

›Nov 21, 2024approval631d agoCARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE (ASPIRIN) — FDA approvalCosette Pharmaceuticals Inc

Sponsor: INGENUS PHARMS NJ. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Nov 21, 2024device 510k631d agoFink Engineering Pty, Ltd. — FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber (510k cleared)

Product code: CBF. Advisory committee: Anesthesiology. Type: Traditional

full page →fda device 510k ↗

›Nov 21, 2024device 510k631d agoVarian Medical Systems, Inc. — Gating Reflector Block (510k cleared)MERIT MEDICAL SYSTEMS INC

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

full page →fda device 510k ↗

›Nov 21, 2024device 510k631d agoLifenet Health — PliaFX Flo (510k cleared)

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

full page →fda device 510k ↗

›Nov 21, 2024device 510k631d agoIlooda Co,., Ltd. — Secret MAX Multi-platform RF System (510k cleared)

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

full page →fda device 510k ↗

›Nov 21, 2024device 510k631d agoKonica Minolta, Inc. — SKR 3000 (510k cleared)

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

full page →fda device 510k ↗

›Nov 21, 2024device 510k631d agoGM Dos Reis Industria e Comercio Ltda. — Versalock Mini and Micro Plating System (510k cleared)

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

full page →fda device 510k ↗

›Nov 21, 2024device 510k631d agoGeneral Vibronics, Inc. — MIRARI® Cold Plasma System ( GV-M2-01) (510k cleared)

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

full page →fda device 510k ↗

›Nov 21, 2024device 510k631d agoSurGenTec, LLC — TiLink-P Joint Fusion System (510k cleared)

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

full page →fda device 510k ↗

›Nov 21, 2024device 510k631d agoShenzhen Smallsignal Technology Co., Ltd. — Fingertip Pulse Oximeter, models Alpine20, Alpine20A, Alpine20H, Alpine20HA, Alpine20B, Alpine20BA, Alpine20BH, Alpine20BHA, Alpine30, Alpine30A, Alpine30H, Alpine30HA, Alpine30B, Alpine30BA, Alpine30BH, Alpine30BHA, Alpine20L, Alpine20LB, Alpine20LH, Alpine20LBH, Alpine30L, Alpine30LB, Alpine30LH, Alpine30LBH (510k cleared)

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

full page →fda device 510k ↗

›Nov 21, 2024device 510k631d agoColoplast Corp. — Luja Coude (510k cleared)

Product code: EZD. Advisory committee: Gastroenterology, Urology. Type: Traditional

full page →fda device 510k ↗

›Nov 21, 2024device 510k631d agoJazz Imaging — Jazz Classic (510k cleared)

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

full page →fda device 510k ↗

›Nov 21, 2024device 510k631d agoCepheid® — Xpert vanA (510k cleared)

Product code: NIJ. Advisory committee: Microbiology. Type: Special

full page →fda device 510k ↗

›Nov 21, 2024device 510k631d agoDepuy Ireland UC — ATTUNE Revision Hinge Knee (510k cleared)