Calendar

Week of Dec 22, 2025

Dec 23, 2025approval250d agoTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗

Dec 23, 2025approval250d agoEPHEDRINE SULFATE — FDA approvalFresenius Kabi USA LLC

Sponsor: CIVICA. Form: SOLUTION. Route: INTRAVENOUS

full page →fda approvals ↗

Dec 23, 2025approval250d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: CHARTWELL. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Dec 23, 2025approval250d agoNALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE (NALOXONE HYDROCHLORIDE) — FDA approvalLupin Ltd

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

full page →fda approvals ↗

Dec 23, 2025approval250d agoIDACIO (ADALIMUMAB-AACF) — FDA approvalIDACIO

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

full page →IDACIO →fda approvals ↗

Dec 23, 2025approval250d agoTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: ZYDUS PHARMS USA INC. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Dec 23, 2025approval250d agoORLYNVAH (PROBENECID) — FDA approvalLannett Co Inc

Sponsor: ITERUM THERAP. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 23, 2025approval250d agoOXYCODONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: ALKEM LABS LTD. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

Dec 23, 2025approval250d agoMETHADOSE (METHADONE HYDROCHLORIDE) — FDA approvalMETHADONE HYDROCHLORIDE

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

full page →METHADONE HYDROCHLORIDE →fda approvals ↗

Dec 23, 2025approval250d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

Dec 23, 2025approval250d agoPROMETHAZINE WITH CODEINE (CODEINE PHOSPHATE) — FDA approvalCosette Pharmaceuticals Inc

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

full page →fda approvals ↗

Dec 23, 2025approval250d agoYONDELIS (TRABECTEDIN) — FDA approvalJOHNSON & JOHNSON

Sponsor: JANSSEN PRODS. Form: POWDER. Route: INTRAVENOUS

full page →fda approvals ↗

Dec 23, 2025approval250d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

full page →fda approvals ↗

Dec 23, 2025approval250d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

Sponsor: RUBICON RESEARCH. Form: TABLET. Route: ORAL

full page →tramadol hydrochloride ER →fda approvals ↗

Dec 23, 2025approval250d agoPYRUKYND (MITAPIVAT SULFATE) — FDA approvalAGIOS PHARMACEUTICALS, INC.

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

full page →fda approvals ↗

Dec 23, 2025approval250d agoMETHYLENE BLUE — FDA approvalMETHYLENE BLUE

Sponsor: CHENGDU SHUODE. Form: SOLUTION. Route: INTRAVENOUS

full page →METHYLENE BLUE →fda approvals ↗

Dec 23, 2025approval250d agoORLADEYO (BEROTRALSTAT DIHYDROCHLORIDE) — FDA approvalberotralstat hydrochloride

Sponsor: BIOCRYST. Form: CAPSULE. Route: ORAL

full page →berotralstat hydrochloride →fda approvals ↗

Dec 23, 2025approval250d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

Sponsor: MYLAN. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →tramadol hydrochloride ER →fda approvals ↗

Dec 23, 2025approval250d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

Sponsor: ACTAVIS ELIZABETH. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →tramadol hydrochloride ER →fda approvals ↗

Dec 23, 2025approval250d agoTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalAurobindo Pharma Ltd

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

full page →fda approvals ↗

Dec 23, 2025approval250d agoTRAMADOL HYDROCHLORIDE — FDA approvalGraviti Pharmaceuticals Inc

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

full page →fda approvals ↗

Dec 23, 2025approval250d agoMETHADONE HYDROCHLORIDE — FDA approvalMETHADONE HYDROCHLORIDE

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

full page →METHADONE HYDROCHLORIDE →fda approvals ↗

Dec 23, 2025approval250d agoTRAMADOL HYDROCHLORIDE — FDA approvalTrigen Laboratories Inc

Sponsor: PLIVA. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 23, 2025approval250d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: ALVOGEN. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Dec 23, 2025approval250d agoOXYMORPHONE HYDROCHLORIDE — FDA approvalOXYMORPHONE HYDROCHLORIDE

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

full page →OXYMORPHONE HYDROCHLORIDE →fda approvals ↗

Dec 23, 2025approval250d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

Sponsor: WATSON LABS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 23, 2025approval250d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

Dec 23, 2025approval250d agoCABLIVI (CAPLACIZUMAB-YHDP) — FDA approvalGenzyme Corp

Sponsor: ABLYNX NV. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Dec 23, 2025approval250d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

full page →fda approvals ↗

Dec 23, 2025approval250d agoPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (CODEINE PHOSPHATE) — FDA approvalPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE

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

full page →PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE →fda approvals ↗

Dec 23, 2025approval250d agoOXYCODONE HYDROCHLORIDE — FDA approvalANI PHARMACEUTICALS INC

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

full page →fda approvals ↗

Dec 23, 2025approval250d agoTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: RISING. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Dec 23, 2025approval250d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

Dec 23, 2025approval250d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

Sponsor: LUPIN LTD. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →tramadol hydrochloride ER →fda approvals ↗

Dec 23, 2025approval250d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

full page →fda approvals ↗

Dec 23, 2025approval250d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

full page →fda approvals ↗

Dec 23, 2025approval250d agoYARTEMLEA (NARSOPLIMAB-WUUG) — FDA approvalnarsoplimab

Sponsor: OMEROS CORP. Form: INJECTION

full page →narsoplimab →fda approvals ↗

Dec 23, 2025approval250d agoOXYCODONE HYDROCHLORIDE AND IBUPROFEN (IBUPROFEN) — FDA approvalMidol

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

full page →Midol →fda approvals ↗

Dec 23, 2025approval250d agoOTEZLA (APREMILAST) — FDA approvalapremilast

Sponsor: AMGEN INC. Form: TABLET. Route: ORAL

full page →apremilast →fda approvals ↗

Dec 23, 2025approval250d agoMETHADONE HYDROCHLORIDE — FDA approvalMETHADONE HYDROCHLORIDE

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

full page →METHADONE HYDROCHLORIDE →fda approvals ↗

Dec 23, 2025approval250d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

Sponsor: SANKALP LIFECARE. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

Dec 23, 2025approval250d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

full page →fda approvals ↗

Dec 23, 2025approval250d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

Sponsor: WATSON LABS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 23, 2025approval250d agoHUMIRA (ADALIMUMAB) — FDA approvaladalimumab

Sponsor: ABBVIE INC. Form: VIAL

full page →adalimumab →fda approvals ↗

Dec 23, 2025approval250d agoGLYCOPYRROLATE — FDA approvalGLYCOPYRROLATE

Sponsor: BIONPHARMA. Form: SOLUTION. Route: ORAL

full page →GLYCOPYRROLATE →fda approvals ↗

Dec 23, 2025device 510k250d agoShenzhen Siken 3D Technology Development Co., Ltd. — Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209) (510k cleared)

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

full page →fda device 510k ↗

Dec 23, 2025device 510k250d agoNakanishi, Inc. — VarioSurg 4 (510k cleared)

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

full page →fda device 510k ↗

Dec 23, 2025device 510k250d agoUpdoc, Inc. — UpDoc (510k cleared)

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

full page →fda device 510k ↗

Dec 23, 2025device 510k250d agoDiasorin Molecular, LLC — LIAISON NES FLU A/B, RSV & COVID-19 (510k cleared)

Product code: QOF. Advisory committee: Microbiology. Type: Dual Track

full page →fda device 510k ↗

Dec 23, 2025device 510k250d agoHealgen Scientific,, LLC — Healgen® URS Test Strips (510k cleared)

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

full page →fda device 510k ↗

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Week of Dec 22, 2025