Calendar

Dec 15, 2023approval992d agoHYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE) — FDA approvalhydrocodone bitartrate ER

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

full page →hydrocodone bitartrate ER →fda approvals ↗

Dec 15, 2023approval992d agoHYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE) — FDA approvalhydrocodone bitartrate ER

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

full page →hydrocodone bitartrate ER →fda approvals ↗

Dec 15, 2023approval992d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

Dec 15, 2023approval992d agoNALBUPHINE HYDROCHLORIDE — FDA approvalNALBUPHINE HYDROCHLORIDE

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

full page →NALBUPHINE HYDROCHLORIDE →fda approvals ↗

Dec 15, 2023approval992d agoMORPHINE SULFATE — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: IMPAX LABS INC. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Dec 15, 2023approval992d agoMORPHINE SULFATE — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: IMPAX LABS INC. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Dec 15, 2023approval992d agoFENTANYL CITRATE — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: EXELA PHARMA. Form: SOLUTION. Route: INTRAVENOUS

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Dec 15, 2023approval992d agoMEPERIDINE HYDROCHLORIDE — FDA approvalHikma Pharmaceuticals Plc

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

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Dec 15, 2023approval992d agoMEPERIDINE HYDROCHLORIDE — FDA approvalHikma Pharmaceuticals Plc

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

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Dec 15, 2023approval992d agoNALBUPHINE HYDROCHLORIDE — FDA approvalNALBUPHINE HYDROCHLORIDE

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

full page →NALBUPHINE HYDROCHLORIDE →fda approvals ↗

Dec 15, 2023approval992d agoNALBUPHINE HYDROCHLORIDE — FDA approvalNALBUPHINE HYDROCHLORIDE

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

full page →NALBUPHINE HYDROCHLORIDE →fda approvals ↗

Dec 15, 2023approval992d agoMETHADONE HYDROCHLORIDE — FDA approvalMETHADONE HYDROCHLORIDE

Sponsor: HIKMA. Form: TABLET. Route: ORAL

full page →METHADONE HYDROCHLORIDE →fda approvals ↗

Dec 15, 2023approval992d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: CHARTWELL. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Dec 15, 2023approval992d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: CHARTWELL. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Dec 15, 2023approval992d agoACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

Sponsor: PHARMOBEDIENT. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 15, 2023approval992d agoXTRELUS (GUAIFENESIN) — FDA approvalECI Pharmaceuticals LLC

Sponsor: ECI PHARMS LLC. Form: TABLET. Route: ORAL

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Dec 15, 2023approval992d agoMEPERIDINE HYDROCHLORIDE — FDA approvalMEPERIDINE HYDROCHLORIDE

Sponsor: HIKMA. Form: SYRUP. Route: ORAL

full page →MEPERIDINE HYDROCHLORIDE →fda approvals ↗

Dec 15, 2023approval992d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: CHARTWELL. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Dec 15, 2023approval992d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: CHARTWELL. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Dec 15, 2023approval992d agoFLOWTUSS (GUAIFENESIN) — FDA approvalMoberg Pharma AB

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

full page →fda approvals ↗

Dec 15, 2023approval992d agoNALBUPHINE HYDROCHLORIDE — FDA approvalNALBUPHINE HYDROCHLORIDE

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

full page →NALBUPHINE HYDROCHLORIDE →fda approvals ↗

Dec 15, 2023approval992d agoMORPHINE SULFATE — FDA approvalKapanol

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

full page →Kapanol →fda approvals ↗

Dec 15, 2023approval992d agoMORPHINE SULFATE — FDA approvalKapanol

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

full page →Kapanol →fda approvals ↗

Dec 15, 2023approval992d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: CHARTWELL. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Dec 15, 2023approval992d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: CHARTWELL. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Dec 15, 2023approval992d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: CHARTWELL. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Dec 15, 2023approval992d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: CHARTWELL. Form: SOLUTION. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Dec 15, 2023approval992d agoXTAMPZA ER (OXYCODONE) — FDA approvaloxycodone ER

Sponsor: COLLEGIUM PHARM INC. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →oxycodone ER →fda approvals ↗

Dec 15, 2023approval992d agoMEPERIDINE HYDROCHLORIDE — FDA approvalMEPERIDINE HYDROCHLORIDE

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

full page →MEPERIDINE HYDROCHLORIDE →fda approvals ↗

Dec 15, 2023approval992d agoMEPERIDINE HYDROCHLORIDE — FDA approvalMEPERIDINE HYDROCHLORIDE

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

full page →MEPERIDINE HYDROCHLORIDE →fda approvals ↗

Dec 15, 2023approval992d agoPHENERGAN W/ CODEINE (CODEINE PHOSPHATE) — FDA approvalANI PHARMACEUTICALS INC

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

full page →fda approvals ↗

Dec 15, 2023approval992d agoMETHADONE HYDROCHLORIDE — FDA approvalMETHADONE HYDROCHLORIDE

Sponsor: HIKMA. Form: SOLUTION. Route: ORAL

full page →METHADONE HYDROCHLORIDE →fda approvals ↗

Dec 15, 2023approval992d agoMORPHINE SULFATE — FDA approvalKapanol

Sponsor: FRESENIUS KABI USA. Form: SOLUTION. Route: INTRAMUSCULAR, INTRAVENOUS

full page →Kapanol →fda approvals ↗

Dec 15, 2023approval992d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

Dec 15, 2023approval992d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

Dec 15, 2023approval992d agoMORPHINE SULFATE — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: TEVA PHARMS USA. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Dec 15, 2023approval992d agoMORPHINE SULFATE — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: TEVA PHARMS USA. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Dec 15, 2023approval992d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

full page →fda approvals ↗

Dec 15, 2023approval992d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

full page →fda approvals ↗

Dec 15, 2023approval992d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

Dec 15, 2023approval992d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

Dec 15, 2023approval992d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalIGC Pharma, Inc.

Sponsor: BARR. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗

Dec 15, 2023approval992d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

Dec 15, 2023approval992d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

Dec 15, 2023approval992d agoPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (CODEINE PHOSPHATE) — FDA approvalPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE

Sponsor: QUAGEN. Form: SYRUP. Route: ORAL

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

Dec 15, 2023approval992d agoPROMETH VC W/ CODEINE (CODEINE PHOSPHATE) — FDA approvalCosette Pharmaceuticals Inc

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

full page →fda approvals ↗

Dec 15, 2023approval992d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

Dec 15, 2023approval992d agoZUBSOLV (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalEdenbridge Pharmaceuticals LLC

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

full page →fda approvals ↗

Dec 15, 2023approval992d agoROXICODONE (OXYCODONE HYDROCHLORIDE) — FDA approvalOXYCODONE HYDROCHLORIDE

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

full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗

Dec 15, 2023approval992d agoFENTANYL CITRATE — FDA approvalEffentora

Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

full page →Effentora →fda approvals ↗

Week of Dec 11, 2023