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pharmadog

Week of Dec 22, 2025

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

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

full page →fda approvals ↗

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

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

full page →fda approvals ↗

Dec 22, 2025approval251d agoFENTANYL-100 (FENTANYL) — FDA approvalZydus Therapeutics Inc

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

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Dec 22, 2025approval251d agoBUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE (ASPIRIN) — FDA approvalNovitium Pharma LLC

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

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Dec 22, 2025approval251d agoTRAMADOL HYDROCHLORIDE — FDA approvalTrigen Laboratories Inc

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

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Dec 22, 2025approval251d agoACTIQ (FENTANYL CITRATE) — FDA approvalTeva Pharmaceuticals USA Inc

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

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Dec 22, 2025approval251d agoBUTORPHANOL TARTRATE — FDA approvalBUTORPHANOL TARTRATE

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

full page →BUTORPHANOL TARTRATE →fda approvals ↗

Dec 22, 2025approval251d agoBUTORPHANOL TARTRATE — FDA approvalBUTORPHANOL TARTRATE

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

full page →BUTORPHANOL TARTRATE →fda approvals ↗

Dec 22, 2025approval251d agoMEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE (MEPERIDINE HYDROCHLORIDE) — FDA approvalHikma Pharmaceuticals Plc

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

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Dec 22, 2025approval251d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

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

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

Dec 22, 2025approval251d agoBUTORPHANOL TARTRATE — FDA approvalHospira Inc

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

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

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

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

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

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

Sponsor: GRANULES. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

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

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

full page →acetaminophen ER →fda approvals ↗

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

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

full page →acetaminophen ER →fda approvals ↗

Dec 22, 2025approval251d agoNALBUPHINE HYDROCHLORIDE — FDA approvalNALBUPHINE HYDROCHLORIDE

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

full page →NALBUPHINE HYDROCHLORIDE →fda approvals ↗

Dec 22, 2025approval251d agoOXYMORPHONE HYDROCHLORIDE — FDA approvalOXYMORPHONE HYDROCHLORIDE

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

full page →OXYMORPHONE HYDROCHLORIDE →fda approvals ↗

Dec 22, 2025approval251d agoDEMEROL (MEPERIDINE HYDROCHLORIDE) — FDA approvalMEPERIDINE HYDROCHLORIDE

Sponsor: QUAGEN. Form: TABLET. Route: ORAL

full page →MEPERIDINE HYDROCHLORIDE →fda approvals ↗

Dec 22, 2025approval251d agoNALBUPHINE HYDROCHLORIDE — FDA approvalNALBUPHINE HYDROCHLORIDE

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

full page →NALBUPHINE HYDROCHLORIDE →fda approvals ↗

Dec 22, 2025approval251d agoMORPHINE SULFATE — FDA approvalKapanol

Sponsor: HIKMA. Form: SOLUTION. Route: ORAL

full page →Kapanol →fda approvals ↗

Dec 22, 2025approval251d agoMEPERIDINE HYDROCHLORIDE — FDA approvalMEPERIDINE HYDROCHLORIDE

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

full page →MEPERIDINE HYDROCHLORIDE →fda approvals ↗

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

Sponsor: MIKART. Form: SOLUTION. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Dec 22, 2025approval251d agoMEPERGAN (MEPERIDINE HYDROCHLORIDE) — FDA approvalMEPERIDINE HYDROCHLORIDE

Sponsor: HIKMA. Form: INJECTABLE. Route: INJECTION

full page →MEPERIDINE HYDROCHLORIDE →fda approvals ↗

Dec 22, 2025approval251d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalTeva Pharmaceuticals USA Inc

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

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Dec 22, 2025approval251d agoHYDROMORPHONE HYDROCHLORIDE — FDA approvalSpecGx LLC

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

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Dec 22, 2025approval251d agoHYDROMORPHONE HYDROCHLORIDE — FDA approvalSpecGx LLC

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

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Dec 22, 2025approval251d agoMORPHINE SULFATE — FDA approvalKapanol

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

full page →Kapanol →fda approvals ↗

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

Sponsor: MIKART. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Dec 22, 2025approval251d agoMORPHINE SULFATE — FDA approvalKapanol

Sponsor: HIKMA. Form: TABLET. Route: ORAL

full page →Kapanol →fda approvals ↗

Dec 22, 2025approval251d agoOXYMORPHONE HYDROCHLORIDE — FDA approvalOXYMORPHONE HYDROCHLORIDE

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

full page →OXYMORPHONE HYDROCHLORIDE →fda approvals ↗

Dec 22, 2025approval251d agoMORPHINE SULFATE — FDA approvalKapanol

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

full page →Kapanol →fda approvals ↗

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

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

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

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

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

Sponsor: GRANULES. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Dec 22, 2025approval251d agoBUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE (ASPIRIN) — FDA approvalNovitium Pharma LLC

Sponsor: STEVENS J. Form: CAPSULE. Route: ORAL

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

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

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

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

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

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

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Dec 22, 2025approval251d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalAmneal Pharmaceuticals, Inc.

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

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

Sponsor: HIBROW HLTHCARE. Form: TABLET. Route: ORAL

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Dec 22, 2025approval251d agoOLINVYK (OLICERIDINE) — FDA approvalOLINVYK

Sponsor: TREVENA. Form: SOLUTION. Route: INTRAVENOUS

full page →OLINVYK →fda approvals ↗

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

Sponsor: BDSI. Form: FILM. Route: BUCCAL

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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 agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalIGC Pharma, Inc.

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

full page →fda approvals ↗

Dec 22, 2025approval251d agoFENTANYL-37 (FENTANYL) — FDA approvalfentanyl ER

Sponsor: MYLAN TECHNOLOGIES. Form: FILM, EXTENDED RELEASE. Route: TRANSDERMAL

full page →fentanyl ER →fda approvals ↗

Dec 22, 2025approval251d agoFENTANYL-37 (FENTANYL) — FDA approvalfentanyl ER

Sponsor: MYLAN TECHNOLOGIES. Form: FILM, EXTENDED RELEASE. Route: TRANSDERMAL

full page →fentanyl ER →fda approvals ↗

Dec 22, 2025approval251d agoFENTANYL-37 (FENTANYL) — FDA approvalfentanyl ER

Sponsor: MYLAN TECHNOLOGIES. Form: FILM, EXTENDED RELEASE. Route: TRANSDERMAL

full page →fentanyl ER →fda approvals ↗

Dec 22, 2025approval251d agoFIORICET W/ CODEINE (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

Sponsor: ACTAVIS LABS UT INC. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

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Week of Dec 22, 2025