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pharmadog

Week of Dec 22, 2025

Dec 22, 2025approval239d agoMETHADONE HYDROCHLORIDE — FDA approvalMETHADONE HYDROCHLORIDE

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

full page →METHADONE HYDROCHLORIDE →fda approvals ↗

Dec 22, 2025approval239d agoALFENTA (ALFENTANIL HYDROCHLORIDE) — FDA approvalalfentanil hydrochloride

Sponsor: RISING. Form: INJECTABLE. Route: INJECTION

full page →alfentanil hydrochloride →fda approvals ↗

Dec 22, 2025approval239d agoHYDROMORPHONE HYDROCHLORIDE — FDA approvalHYDROMORPHONE HYDROCHLORIDE

Sponsor: HIKMA. Form: SOLUTION. Route: INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

full page →HYDROMORPHONE HYDROCHLORIDE →fda approvals ↗

Dec 22, 2025approval239d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalIGC Pharma, Inc.

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

full page →fda approvals ↗

Dec 22, 2025approval239d agoBUTORPHANOL TARTRATE PRESERVATIVE FREE (BUTORPHANOL TARTRATE) — FDA approvalBUTORPHANOL TARTRATE

Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

full page →BUTORPHANOL TARTRATE →fda approvals ↗

Dec 22, 2025approval239d agoPERCOCET (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

Sponsor: OZANTRI. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 22, 2025approval239d agoMORPHINE SULFATE — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: UPSHER SMITH LABS. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Dec 22, 2025approval239d agoFUROSCIX (FUROSEMIDE) — FDA approvalFurosemide Sun

Sponsor: SCPHARMACEUTICALS. Form: SOLUTION. Route: SUBCUTANEOUS

full page →Furosemide Sun →fda approvals ↗

Dec 22, 2025approval239d agoMUCINEX 12HR COLD & FEVER MULTI-SYMPTOM (DEXTROMETHORPHAN HYDROBROMIDE) — FDA approvalHetero Labs Ltd

Sponsor: RB HLTH. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Dec 22, 2025approval239d agoLEVORPHANOL TARTRATE — FDA approvalLEVORPHANOL TARTRATE

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

full page →LEVORPHANOL TARTRATE →fda approvals ↗

Dec 22, 2025approval239d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

Dec 22, 2025approval239d agoMEPERIDINE HYDROCHLORIDE — FDA approvalHikma Pharmaceuticals Plc

Sponsor: GENUS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 22, 2025approval239d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

Sponsor: GENUS. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

Dec 22, 2025approval239d agoLEVORPHANOL TARTRATE — FDA approvalLEVORPHANOL TARTRATE

Sponsor: HIKMA. Form: TABLET. Route: ORAL

full page →LEVORPHANOL TARTRATE →fda approvals ↗

Dec 22, 2025approval239d agoLEVORPHANOL TARTRATE — FDA approvalLEVORPHANOL TARTRATE

Sponsor: HIKMA. Form: TABLET. Route: ORAL

full page →LEVORPHANOL TARTRATE →fda approvals ↗

Dec 22, 2025approval239d agoNUBAIN (NALBUPHINE HYDROCHLORIDE) — FDA approvalTrevi Therapeutics, Inc.

Sponsor: PH HEALTH. Form: SOLUTION. Route: INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

full page →fda approvals ↗

Dec 22, 2025approval239d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

full page →fda approvals ↗

Dec 22, 2025approval239d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

full page →fda approvals ↗

Dec 22, 2025approval239d agoFENTANYL-100 (FENTANYL) — FDA approvalZydus Therapeutics Inc

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

full page →fda approvals ↗

Dec 22, 2025approval239d agoBUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE (ASPIRIN) — FDA approvalNovitium Pharma LLC

Sponsor: LGM PHARMA. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Dec 22, 2025approval239d agoTRAMADOL HYDROCHLORIDE — FDA approvalTrigen Laboratories Inc

Sponsor: PURACAP LABS BLU. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 22, 2025approval239d agoACTIQ (FENTANYL CITRATE) — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: CEPHALON. Form: TROCHE/LOZENGE. Route: TRANSMUCOSAL

full page →fda approvals ↗

Dec 22, 2025approval239d agoBUTORPHANOL TARTRATE — FDA approvalBUTORPHANOL TARTRATE

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

full page →BUTORPHANOL TARTRATE →fda approvals ↗

Dec 22, 2025approval239d agoBUTORPHANOL TARTRATE — FDA approvalBUTORPHANOL TARTRATE

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

full page →BUTORPHANOL TARTRATE →fda approvals ↗

Dec 22, 2025approval239d agoMEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE (MEPERIDINE HYDROCHLORIDE) — FDA approvalHikma Pharmaceuticals Plc

Sponsor: WEST-WARD PHARMS INT. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Dec 22, 2025approval239d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: SOMERSET THERAPS LLC. Form: INJECTABLE. Route: INJECTION

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

Dec 22, 2025approval239d agoBUTORPHANOL TARTRATE — FDA approvalHospira Inc

Sponsor: HIKMA FARMACEUTICA. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Dec 22, 2025approval239d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalEon Labs Inc

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

full page →fda approvals ↗

Dec 22, 2025approval239d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalEon Labs Inc

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

full page →fda approvals ↗

Dec 22, 2025approval239d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: GRANULES. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Dec 22, 2025approval239d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

Dec 22, 2025approval239d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

Dec 22, 2025approval239d agoNALBUPHINE HYDROCHLORIDE — FDA approvalNALBUPHINE HYDROCHLORIDE

Sponsor: SOMERSET THERAPS LLC. Form: SOLUTION. Route: INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

full page →NALBUPHINE HYDROCHLORIDE →fda approvals ↗

Dec 22, 2025approval239d agoOXYMORPHONE HYDROCHLORIDE — FDA approvalOXYMORPHONE HYDROCHLORIDE

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

full page →OXYMORPHONE HYDROCHLORIDE →fda approvals ↗

Dec 22, 2025approval239d agoDEMEROL (MEPERIDINE HYDROCHLORIDE) — FDA approvalMEPERIDINE HYDROCHLORIDE

Sponsor: QUAGEN. Form: TABLET. Route: ORAL

full page →MEPERIDINE HYDROCHLORIDE →fda approvals ↗

Dec 22, 2025approval239d agoNALBUPHINE HYDROCHLORIDE — FDA approvalNALBUPHINE HYDROCHLORIDE

Sponsor: SOMERSET THERAPS LLC. Form: SOLUTION. Route: INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

full page →NALBUPHINE HYDROCHLORIDE →fda approvals ↗

Dec 22, 2025approval239d agoMORPHINE SULFATE — FDA approvalKapanol

Sponsor: HIKMA. Form: SOLUTION. Route: ORAL

full page →Kapanol →fda approvals ↗

Dec 22, 2025approval239d agoMEPERIDINE HYDROCHLORIDE — FDA approvalMEPERIDINE HYDROCHLORIDE

Sponsor: SUN PHARM INDUSTRIES. Form: TABLET. Route: ORAL

full page →MEPERIDINE HYDROCHLORIDE →fda approvals ↗

Dec 22, 2025approval239d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: MIKART. Form: SOLUTION. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Dec 22, 2025approval239d agoMEPERGAN (MEPERIDINE HYDROCHLORIDE) — FDA approvalMEPERIDINE HYDROCHLORIDE

Sponsor: HIKMA. Form: INJECTABLE. Route: INJECTION

full page →MEPERIDINE HYDROCHLORIDE →fda approvals ↗

Dec 22, 2025approval239d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: TEVA PHARMS USA. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗

Dec 22, 2025approval239d agoHYDROMORPHONE HYDROCHLORIDE — FDA approvalSpecGx LLC

Sponsor: ACTAVIS LABS FL INC. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Dec 22, 2025approval239d agoHYDROMORPHONE HYDROCHLORIDE — FDA approvalSpecGx LLC

Sponsor: ACTAVIS LABS FL INC. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Dec 22, 2025approval239d agoMORPHINE SULFATE — FDA approvalKapanol

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

full page →Kapanol →fda approvals ↗

Dec 22, 2025approval239d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: MIKART. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Dec 22, 2025approval239d agoMORPHINE SULFATE — FDA approvalKapanol

Sponsor: HIKMA. Form: TABLET. Route: ORAL

full page →Kapanol →fda approvals ↗

Dec 22, 2025approval239d agoOXYMORPHONE HYDROCHLORIDE — FDA approvalOXYMORPHONE HYDROCHLORIDE

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

full page →OXYMORPHONE HYDROCHLORIDE →fda approvals ↗

Dec 22, 2025approval239d agoMORPHINE SULFATE — FDA approvalKapanol

Sponsor: HOSPIRA INC. Form: INJECTABLE. Route: INJECTION

full page →Kapanol →fda approvals ↗

Dec 22, 2025approval239d agoMORPHINE SULFATE — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: INTL MEDICATION SYS. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Dec 22, 2025approval239d agoMORPHINE SULFATE — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: INTL MEDICATION SYS. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

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Week of Dec 22, 2025