Calendar

pharmadog

Week of Oct 28, 2024

Oct 31, 2024approval651d agoNUCYNTA ER (TAPENTADOL HYDROCHLORIDE) — FDA approvaltapentadol hydrochloride ER

Sponsor: COLLEGIUM PHARM INC. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →tapentadol hydrochloride ER →fda approvals ↗

Oct 31, 2024approval651d agoMETHADONE HYDROCHLORIDE — FDA approvalMETHADONE HYDROCHLORIDE

Sponsor: SPECGX LLC. Form: TABLET. Route: ORAL

full page →METHADONE HYDROCHLORIDE →fda approvals ↗

Oct 31, 2024approval651d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

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

full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗

Oct 31, 2024approval651d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

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

full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗

Oct 31, 2024approval651d agoMETHADONE HYDROCHLORIDE — FDA approvalMETHADONE HYDROCHLORIDE

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

full page →METHADONE HYDROCHLORIDE →fda approvals ↗

Oct 31, 2024approval651d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

Sponsor: PHARM ASSOC. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

Oct 31, 2024approval651d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

Sponsor: PHARM ASSOC. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

Oct 31, 2024approval651d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: ALVOGEN. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Oct 31, 2024approval651d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

Oct 31, 2024approval651d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

Sponsor: STRIDES PHARMA INTL. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →tramadol hydrochloride ER →fda approvals ↗

Oct 31, 2024approval651d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

Sponsor: PH HEALTH. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Oct 31, 2024approval651d agoMETHADONE HYDROCHLORIDE — FDA approvalMETHADONE HYDROCHLORIDE

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

full page →METHADONE HYDROCHLORIDE →fda approvals ↗

Oct 31, 2024approval651d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: ACTAVIS MID ATLANTIC. Form: SOLUTION. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Oct 31, 2024approval651d agoROXICET (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: HIKMA. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Oct 31, 2024approval651d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalEon Labs Inc

Sponsor: PHARMOBEDIENT. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

Oct 31, 2024approval651d agoCARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE (ASPIRIN) — FDA approvalCosette Pharmaceuticals Inc

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

full page →fda approvals ↗

Oct 31, 2024approval651d agoOXAYDO (OXYCODONE HYDROCHLORIDE) — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: ZYLA. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Oct 31, 2024approval651d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: ALVOGEN. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Oct 31, 2024approval651d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: ABHAI LLC. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Oct 31, 2024approval651d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalEon Labs Inc

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

full page →fda approvals ↗

Oct 31, 2024approval651d agoBUTORPHANOL TARTRATE — FDA approvalBUTORPHANOL TARTRATE

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

full page →BUTORPHANOL TARTRATE →fda approvals ↗

Oct 31, 2024approval651d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

Oct 31, 2024approval651d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: ASCENT PHARMS INC. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Oct 31, 2024approval651d agoLEVORPHANOL TARTRATE — FDA approvalLEVORPHANOL TARTRATE

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

full page →LEVORPHANOL TARTRATE →fda approvals ↗

Oct 31, 2024approval651d agoMORPHINE SULFATE — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: ANDA REPOSITORY. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Oct 31, 2024approval651d agoFENTANYL-100 (FENTANYL) — FDA approvalNiu Technologies

Sponsor: KINDEVA. Form: FILM, EXTENDED RELEASE. Route: TRANSDERMAL

full page →fda approvals ↗

Oct 31, 2024approval651d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: MIKART. Form: SOLUTION. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Oct 31, 2024approval651d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

Oct 31, 2024approval651d agoLEVORPHANOL TARTRATE — FDA approvalSpecGx LLC

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

full page →fda approvals ↗

Oct 31, 2024approval651d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: WES PHARMA INC. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Oct 31, 2024approval651d agoOXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: PH HEALTH. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

Oct 31, 2024approval651d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

Sponsor: ASCENT PHARMS INC. Form: TABLET. Route: ORAL

full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗

Oct 31, 2024approval651d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

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

full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗

Oct 31, 2024device 510k651d agoShenzhen Mindray Bio-Medical Electronics Co., Ltd. — V80 Anesthetic Vaporizer (V80) (510k cleared)

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

full page →fda device 510k ↗

Oct 31, 2024device 510k651d agoBard Access Systems, Inc. — PowerPort ClearVUE Slim Implantable Ports and PowerPort ClearVUE Slim Implantable Ports (510k cleared)

Product code: LJT. Advisory committee: General Hospital. Type: Special

full page →fda device 510k ↗

Oct 31, 2024device 510k651d agoBecton, Dickinson and Company — BD Vacutainer® Citrate Blood Collection Tubes (510k cleared)BECTON DICKINSON & CO

Product code: GIM. Advisory committee: Clinical Chemistry. Type: Traditional

full page →fda device 510k ↗

Oct 31, 2024device 510k651d agoSmartcardia SA — SmartCardia 7L Platform (MCT) (510k cleared)

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

full page →fda device 510k ↗

Oct 31, 2024device 510k651d agoBonebridge AG — Bonebridge Osteosynthesis Plating System (510k cleared)

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

full page →fda device 510k ↗

Oct 31, 2024device 510k651d agoHighness Co., Ltd. — Highness Implant System (510k cleared)

Product code: DZE. Advisory committee: Dental. Type: Traditional

full page →fda device 510k ↗

Oct 31, 2024device 510k651d agoShenzhen Medke Technology Co., Ltd. — Disposable Blood Pressure cuff; Reusable Blood Pressure cuff (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

full page →fda device 510k ↗

Oct 31, 2024device 510k651d agoErad, Inc. — eRAD PACS (510k cleared)

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

full page →fda device 510k ↗

Oct 31, 2024device 510k651d agoBionova Medical, Inc. — Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo (510k cleared)

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

full page →fda device 510k ↗

Nov 1, 2024approval650d agoWEGOVY (SEMAGLUTIDE) — FDA approvalNovo Nordisk AS

Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS

full page →fda approvals ↗

Nov 1, 2024approval650d agoTRULICITY (DULAGLUTIDE) — FDA approvaldulaglutide