Calendar

Week of Dec 22, 2025

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

Sponsor: ETHYPHARM. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

Dec 22, 2025approval251d agoPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (CODEINE PHOSPHATE) — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗

Dec 22, 2025approval251d agoPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (CODEINE PHOSPHATE) — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗

Dec 22, 2025approval251d agoPROSTIN VR PEDIATRIC (ALPROSTADIL) — FDA approvalalprostadil

Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

full page →alprostadil →fda approvals ↗

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

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

full page →acetaminophen ER →fda approvals ↗

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

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

full page →acetaminophen ER →fda approvals ↗

Dec 22, 2025approval251d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

Sponsor: HIKMA. Form: SOLUTION. Route: ORAL

full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗

Dec 22, 2025approval251d agoMETHADONE HYDROCHLORIDE — FDA approvalMETHADONE HYDROCHLORIDE

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

full page →METHADONE HYDROCHLORIDE →fda approvals ↗

Dec 22, 2025approval251d agoMETHADONE HYDROCHLORIDE — FDA approvalMETHADONE HYDROCHLORIDE

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

full page →METHADONE HYDROCHLORIDE →fda approvals ↗

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

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

full page →acetaminophen ER →fda approvals ↗

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

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

full page →acetaminophen ER →fda approvals ↗

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

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

full page →acetaminophen ER →fda approvals ↗

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

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

full page →acetaminophen ER →fda approvals ↗

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

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

full page →acetaminophen ER →fda approvals ↗

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

Sponsor: CHARTWELL. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Dec 22, 2025approval251d agoOXYCODONE HYDROCHLORIDE AND IBUPROFEN (IBUPROFEN) — FDA approvalMidol

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

full page →Midol →fda approvals ↗

Dec 22, 2025approval251d agoHYDROMORPHONE HYDROCHLORIDE — FDA approvalSpecGx LLC

Sponsor: OSMOTICA PHARM US. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

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

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

full page →acetaminophen ER →fda approvals ↗

Dec 22, 2025approval251d agoHYDROMORPHONE HYDROCHLORIDE — FDA approvalHYDROMORPHONE HYDROCHLORIDE

Sponsor: ASCENT PHARMS INC. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →HYDROMORPHONE HYDROCHLORIDE →fda approvals ↗

Dec 22, 2025approval251d agoOXYCONTIN (OXYCODONE HYDROCHLORIDE) — FDA approvalOXYCODONE HYDROCHLORIDE

Sponsor: PURDUE PHARMA LP. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗

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

Sponsor: LANNETT CO INC. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Dec 22, 2025approval251d agoPROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE (CODEINE PHOSPHATE) — FDA approvalPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE

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

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

Dec 22, 2025approval251d agoPROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE (CODEINE PHOSPHATE) — FDA approvalPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE

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

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

Dec 22, 2025approval251d agoMEPERIDINE HYDROCHLORIDE — FDA approvalHikma Pharmaceuticals Plc

Sponsor: BARR. Form: TABLET. Route: ORAL

full page →fda approvals ↗

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

Sponsor: LANNETT CO INC. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Dec 22, 2025approval251d agoMEPERIDINE HYDROCHLORIDE — FDA approvalHikma Pharmaceuticals Plc

Sponsor: BARR. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 22, 2025approval251d agoPROBUPHINE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalIGC Pharma, Inc.

Sponsor: REACX PHARMS. Form: IMPLANT. Route: IMPLANTATION

full page →fda approvals ↗

Dec 22, 2025approval251d agoQDOLO (TRAMADOL HYDROCHLORIDE) — FDA approvaltramadol hydrochloride ER

Sponsor: ROSEMONT. Form: SOLUTION. Route: ORAL

full page →tramadol hydrochloride ER →fda approvals ↗

Dec 22, 2025approval251d agoHYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE) — FDA approvalhydrocodone bitartrate ER

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

full page →hydrocodone bitartrate ER →fda approvals ↗

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

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

full page →acetaminophen ER →fda approvals ↗

Dec 22, 2025approval251d agoHYCOFENIX (GUAIFENESIN) — FDA approvalMoberg Pharma AB

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

full page →fda approvals ↗

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

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

full page →acetaminophen ER →fda approvals ↗

Dec 22, 2025approval251d agoVIVITROL (NALTREXONE) — FDA approvalnaltrexone ER

Sponsor: ALKERMES. Form: FOR SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR

full page →naltrexone ER →fda approvals ↗

Dec 22, 2025approval251d agoPOTASSIUM CHLORIDE — FDA approvalPOTASSIUM CHLORIDE

Sponsor: QUAGEN. Form: SOLUTION. Route: ORAL

full page →POTASSIUM CHLORIDE →fda approvals ↗

Dec 22, 2025approval251d agoDILAUDID-HP (HYDROMORPHONE HYDROCHLORIDE) — FDA approvalHYDROMORPHONE HYDROCHLORIDE

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

full page →HYDROMORPHONE HYDROCHLORIDE →fda approvals ↗

Dec 22, 2025approval251d agoMETHADONE HYDROCHLORIDE — FDA approvalMETHADONE HYDROCHLORIDE

Sponsor: HIKMA. Form: SOLUTION. Route: ORAL

full page →METHADONE HYDROCHLORIDE →fda approvals ↗

Dec 22, 2025approval251d agoMETHADONE HYDROCHLORIDE — FDA approvalMETHADONE HYDROCHLORIDE

Sponsor: HIKMA. Form: SOLUTION. Route: ORAL

full page →METHADONE HYDROCHLORIDE →fda approvals ↗

Dec 22, 2025approval251d agoPERCODAN (ASPIRIN) — FDA approvalEndo Pharmaceuticals Inc

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

full page →fda approvals ↗

Dec 22, 2025approval251d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalIGC Pharma, Inc.

Sponsor: SUN PHARM. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗

Dec 22, 2025approval251d agoPROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE (CODEINE PHOSPHATE) — FDA approvalPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE

Sponsor: HIKMA. Form: SYRUP. Route: ORAL

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

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

Sponsor: HIKMA. Form: SOLUTION. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Dec 22, 2025approval251d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalIGC Pharma, Inc.

Sponsor: AM REGENT. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Dec 22, 2025approval251d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalIGC Pharma, Inc.

Sponsor: AM REGENT. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Dec 22, 2025approval251d agoDURAMORPH PF (MORPHINE SULFATE) — FDA approvalKapanol

Sponsor: HIKMA. Form: INJECTABLE. Route: INJECTION

full page →Kapanol →fda approvals ↗

Dec 22, 2025approval251d agoDURAMORPH PF (MORPHINE SULFATE) — FDA approvalKapanol

Sponsor: HIKMA. Form: INJECTABLE. Route: INJECTION

full page →Kapanol →fda approvals ↗

Dec 22, 2025approval251d agoROXYBOND (OXYCODONE HYDROCHLORIDE) — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗

Dec 22, 2025approval251d agoCODEINE SULFATE — FDA approvalcodeine

Sponsor: HIKMA. Form: SOLUTION. Route: ORAL

full page →codeine →fda approvals ↗

Dec 22, 2025approval251d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: HIKMA. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

Dec 22, 2025approval251d agoFENTANYL-75 (FENTANYL) — FDA approvalDifGen Pharmaceuticals LLC

Sponsor: DIFGEN PHARMS. Form: FILM, EXTENDED RELEASE. Route: TRANSDERMAL

full page →fda approvals ↗

Dec 22, 2025approval251d agoFENTANYL-75 (FENTANYL) — FDA approvalDifGen Pharmaceuticals LLC

Sponsor: DIFGEN PHARMS. Form: FILM, EXTENDED RELEASE. Route: TRANSDERMAL

full page →fda approvals ↗

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Week of Dec 22, 2025