calendar

Dec 22, 2025approval251d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: ALVOGEN. Form: TABLET. Route: ORAL

Dec 22, 2025approval251d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

Dec 22, 2025approval251d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalEon Labs Inc

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

Dec 22, 2025approval251d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalEon Labs Inc

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

full page →BUTORPHANOL TARTRATE →fda approvals ↗

Dec 22, 2025approval251d agoBUTORPHANOL TARTRATE — FDA approvalBUTORPHANOL TARTRATE

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

Dec 22, 2025approval251d agoBUTORPHANOL TARTRATE — FDA approvalBUTORPHANOL TARTRATE

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

full page →BUTORPHANOL TARTRATE →fda approvals ↗

Dec 22, 2025approval251d agoHYCODAN (HOMATROPINE METHYLBROMIDE) — FDA approval

Sponsor: GENUS. Form: SYRUP. Route: ORAL

Dec 22, 2025approval251d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

Dec 22, 2025approval251d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →LEVORPHANOL TARTRATE →fda approvals ↗

Dec 22, 2025approval251d agoLEVORPHANOL TARTRATE — FDA approvalLEVORPHANOL TARTRATE

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

Dec 22, 2025approval251d agoMORPHINE SULFATE — FDA approvalTeva Pharmaceuticals USA Inc

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

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

Dec 22, 2025approval251d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

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

Dec 22, 2025approval251d agoFENTANYL-100 (FENTANYL) — FDA approvalNiu Technologies

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

Dec 22, 2025approval251d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

Dec 22, 2025approval251d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: MIKART. Form: SOLUTION. Route: ORAL

Dec 22, 2025approval251d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

Dec 22, 2025approval251d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

Dec 22, 2025approval251d agoMORPHINE SULFATE — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: CHARTWELL MOLECULAR. Form: SOLUTION. Route: ORAL

Dec 22, 2025approval251d agoLEVORPHANOL TARTRATE — FDA approvalSpecGx LLC

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

Dec 22, 2025device 510k251d agoRaySearch Laboratories AB (PUBL) — RayStation (2024A SP3) (510k cleared)

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

Dec 22, 2025device 510k251d agoTaiwan Surgical Corporation — InnoClip Clip Applier (510k cleared)

Product code: FZP. Advisory committee: General, Plastic Surgery. Type: Special

Dec 22, 2025device 510k251d agoTaiwan Surgical Corporation — InnoClip Disposable Clip Applier (510k cleared)

Product code: FZP. Advisory committee: General, Plastic Surgery. Type: Special

Dec 22, 2025device 510k251d agoIterative Health — SKOUT system (510k cleared)

Product code: QNP. Advisory committee: Gastroenterology, Urology. Type: Special

Dec 22, 2025device 510k251d agoOxos Medical — MC2 Portable X-ray System (510k cleared)

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

Dec 22, 2025device 510k251d agoPression, Inc. — Pression Wave PRO External Counter-Pulsation System (510k cleared)

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

Dec 22, 2025device 510k251d agoBioticsai, Inc. — BioticsAI (510k cleared)

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

Dec 22, 2025device 510k251d agoEmpatica S.r.l. — EmbraceMini (510k cleared)

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

Dec 22, 2025device 510k251d agoGlobus Medical, Inc. — HEDRON Cervical Spacers (HEDRON C-MIS Spacer) (510k cleared)GLOBUS MEDICAL INC

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

Dec 22, 2025device 510k251d agoInstylla, Inc. — Instylla Delivery Kit (510k cleared)

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

Dec 22, 2025device 510k251d agoQingdao Kingon Medical Science and Technology Co., Ltd. — Oxygen Concentrator-P2-O5E (510k cleared)

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

Dec 22, 2025device 510k251d agoTHINK Surgical, Inc. — TMINI Miniature Robotic System (510k cleared)

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

Dec 22, 2025device 510k251d agoDIMPLO, Ltd. — DIMPLO Implant System (510k cleared)

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

Dec 22, 2025device 510k251d agoPhilips Ultrasound, LLC — Lumify Diagnostic Ultrasound System (510k cleared)Ocuvex Therapeutics Inc

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

Dec 22, 2025device 510k251d agoETHICON, Inc. — STRATAFIX Spiral PDS Plus Knotless Tissue Control Device; STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device (510k cleared)

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

Dec 22, 2025device 510k251d agoArthrex, Inc. — Syndesmosis TightRope PRO (510k cleared)

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

Dec 22, 2025device 510k251d agoZhejiang Gongdong Medical Technology Co., Ltd. — Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G) (510k cleared)Zhejiang Xinkanghe Biomedical Technology Co Ltd

Product code: MMK. Advisory committee: General Hospital. Type: Traditional

Dec 22, 2025device 510k251d agoAccurkardia, Inc. — AccurECG Analysis System (v2.0) (510k cleared)

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

Dec 22, 2025device 510k251d agoEmed Technologies Corporation — Tetra (TM-20); Tetra (TM-50) (510k cleared)

Product code: PKP. Advisory committee: General Hospital. Type: Traditional

Dec 22, 2025device 510k251d agoStimlabs, LLC — Theracor (510k cleared)

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

Dec 22, 2025device 510k251d agoShenzhen Homed Medical Device Co., Ltd. — Portable oxygen concentrator (JLO-190P) (510k cleared)

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

Dec 22, 2025device 510k251d agoBioteque Corporation — BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G (510k cleared)

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

Dec 22, 2025device 510k251d agoSorin Group Italia S.R.L. — Inspire HCR and HCR DUAL cardiotomy reservoirs (510k cleared)

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

Dec 22, 2025device 510k251d agoLacerta Life Science — LacertaMatrix (510k cleared)

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

Dec 22, 2025device 510k251d agoPeek Health, S.A. — PeekMed web (510k cleared)

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

Dec 22, 2025device 510k251d agoZhenjiang Assure Medical Equipment Co., Ltd. — Power wheelchair (510k cleared)

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

Dec 22, 2025device 510k251d agoCarlsmed, Inc. — aprevo® cervical plating system (510k cleared)CARLSMED, INC.

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

Dec 22, 2025device 510k251d agoKp Trading Co., Ltd. — KP Protective Face Mask (510k cleared)

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