Calendar

pharmadog

Week of Dec 22, 2025

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

Sponsor: GENUS. Form: SYRUP. Route: ORAL

full page →fda approvals ↗

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

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

full page →acetaminophen ER →fda approvals ↗

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

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

full page →acetaminophen ER →fda approvals ↗

Dec 22, 2025approval251d agoLEVORPHANOL TARTRATE — FDA approvalLEVORPHANOL TARTRATE

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

full page →LEVORPHANOL TARTRATE →fda approvals ↗

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

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

full page →fda approvals ↗

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

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

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

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

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

full page →fda approvals ↗

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

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

full page →fda approvals ↗

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

Sponsor: MIKART. Form: SOLUTION. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

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

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

full page →acetaminophen ER →fda approvals ↗

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

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

full page →acetaminophen ER →fda approvals ↗

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

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

full page →fda approvals ↗

Dec 22, 2025approval251d agoLEVORPHANOL TARTRATE — FDA approvalSpecGx LLC

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

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

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

full page →tramadol hydrochloride ER →fda approvals ↗

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

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

full page →acetaminophen ER →fda approvals ↗

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

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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

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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 ↗

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Week of Dec 22, 2025