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pharmadog

Week of Dec 11, 2023

Dec 15, 2023approval972d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: MIKART. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Dec 15, 2023approval972d agoMORPHINE SULFATE — FDA approvalKapanol

Sponsor: HIKMA. Form: TABLET. Route: ORAL

full page →Kapanol →fda approvals ↗

Dec 15, 2023approval972d agoOXYMORPHONE HYDROCHLORIDE — FDA approvalOXYMORPHONE HYDROCHLORIDE

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

full page →OXYMORPHONE HYDROCHLORIDE →fda approvals ↗

Dec 15, 2023approval972d agoMORPHINE SULFATE — FDA approvalKapanol

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

full page →Kapanol →fda approvals ↗

Dec 15, 2023approval972d agoMORPHINE SULFATE — FDA approvalTeva Pharmaceuticals USA Inc

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

full page →fda approvals ↗

Dec 15, 2023approval972d agoBUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE (ASPIRIN) — FDA approvalNovitium Pharma LLC

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

full page →fda approvals ↗

Dec 15, 2023approval972d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalEon Labs Inc

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

full page →fda approvals ↗

Dec 15, 2023approval972d agoPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (CODEINE PHOSPHATE) — FDA approvalCosette Pharmaceuticals Inc

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

full page →fda approvals ↗

Dec 15, 2023approval972d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗

Dec 15, 2023approval972d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗

Dec 15, 2023approval972d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

full page →fda approvals ↗

Dec 15, 2023approval972d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

full page →fda approvals ↗

Dec 15, 2023approval972d agoOLINVYK (OLICERIDINE) — FDA approvalOLINVYK

Sponsor: TREVENA. Form: SOLUTION. Route: INTRAVENOUS

full page →OLINVYK →fda approvals ↗

Dec 15, 2023approval972d agoBELBUCA (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalIGC Pharma, Inc.

Sponsor: BDSI. Form: FILM. Route: BUCCAL

full page →fda approvals ↗

Dec 15, 2023approval972d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

Dec 15, 2023approval972d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalIGC Pharma, Inc.

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

full page →fda approvals ↗

Dec 15, 2023approval972d agoFENTANYL-37 (FENTANYL) — FDA approvalfentanyl ER

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

full page →fentanyl ER →fda approvals ↗

Dec 15, 2023approval972d agoFIORICET W/ CODEINE (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

full page →fda approvals ↗

Dec 15, 2023approval972d agoDEMEROL (MEPERIDINE HYDROCHLORIDE) — FDA approvalMEPERIDINE HYDROCHLORIDE

Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

full page →MEPERIDINE HYDROCHLORIDE →fda approvals ↗

Dec 15, 2023approval972d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalANI PHARMACEUTICALS INC

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

full page →fda approvals ↗

Dec 15, 2023approval972d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalANI PHARMACEUTICALS INC

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

full page →fda approvals ↗

Dec 15, 2023approval972d agoMETHADONE HYDROCHLORIDE — FDA approvalMETHADONE HYDROCHLORIDE

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

full page →METHADONE HYDROCHLORIDE →fda approvals ↗

Dec 15, 2023approval972d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: ETHYPHARM. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

Dec 15, 2023approval972d agoPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (CODEINE PHOSPHATE) — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗

Dec 15, 2023approval972d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

Dec 15, 2023approval972d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

Dec 15, 2023approval972d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

Dec 15, 2023approval972d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

Dec 15, 2023approval972d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

Dec 15, 2023approval972d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

Dec 15, 2023approval972d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: CHARTWELL. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Dec 15, 2023approval972d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: CHARTWELL. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Dec 15, 2023approval972d agoOXYCODONE HYDROCHLORIDE AND IBUPROFEN (IBUPROFEN) — FDA approvalMidol

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

full page →Midol →fda approvals ↗

Dec 15, 2023approval972d agoOXYCODONE HYDROCHLORIDE AND IBUPROFEN (IBUPROFEN) — FDA approvalMidol

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

full page →Midol →fda approvals ↗

Dec 15, 2023approval972d agoHYDROMORPHONE HYDROCHLORIDE — FDA approvalSpecGx LLC

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

full page →fda approvals ↗

Dec 15, 2023approval972d agoHYDROMORPHONE HYDROCHLORIDE — FDA approvalSpecGx LLC

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

full page →fda approvals ↗

Dec 15, 2023approval972d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

Dec 15, 2023approval972d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

Dec 15, 2023approval972d agoHYDROMORPHONE HYDROCHLORIDE — FDA approvalHYDROMORPHONE HYDROCHLORIDE

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

full page →HYDROMORPHONE HYDROCHLORIDE →fda approvals ↗

Dec 15, 2023approval972d agoHYDROMORPHONE HYDROCHLORIDE — FDA approvalHYDROMORPHONE HYDROCHLORIDE

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

full page →HYDROMORPHONE HYDROCHLORIDE →fda approvals ↗

Dec 15, 2023approval972d agoOXYCONTIN (OXYCODONE HYDROCHLORIDE) — FDA approvalOXYCODONE HYDROCHLORIDE

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

full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗

Dec 15, 2023approval972d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

Dec 15, 2023approval972d 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 15, 2023approval972d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

Dec 15, 2023approval972d agoPROBUPHINE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalIGC Pharma, Inc.

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

full page →fda approvals ↗

Dec 15, 2023approval972d agoQDOLO (TRAMADOL HYDROCHLORIDE) — FDA approvaltramadol hydrochloride ER

Sponsor: ROSEMONT. Form: SOLUTION. Route: ORAL

full page →tramadol hydrochloride ER →fda approvals ↗

Dec 15, 2023approval972d 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 15, 2023approval972d 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 15, 2023approval972d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

Dec 15, 2023approval972d agoHYCOFENIX (GUAIFENESIN) — FDA approvalMoberg Pharma AB

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

full page →fda approvals ↗

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Week of Dec 11, 2023