Calendar

pharmadog

Week of Dec 11, 2023

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

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

full page →fda approvals ↗

Dec 15, 2023approval972d agoALFENTA (ALFENTANIL HYDROCHLORIDE) — FDA approvalalfentanil hydrochloride

Sponsor: RISING. Form: INJECTABLE. Route: INJECTION

full page →alfentanil hydrochloride →fda approvals ↗

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

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

full page →fda approvals ↗

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

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

full page →fda approvals ↗

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

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

full page →acetaminophen ER →fda approvals ↗

Dec 15, 2023approval972d agoMEPERIDINE HYDROCHLORIDE — FDA approvalHikma Pharmaceuticals Plc

Sponsor: GENUS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

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

Sponsor: GENUS. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

Dec 15, 2023approval972d agoLEVORPHANOL TARTRATE — FDA approvalLEVORPHANOL TARTRATE

Sponsor: HIKMA. Form: TABLET. Route: ORAL

full page →LEVORPHANOL TARTRATE →fda approvals ↗

Dec 15, 2023approval972d agoNUBAIN (NALBUPHINE HYDROCHLORIDE) — FDA approvalTrevi Therapeutics, Inc.

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

full page →fda approvals ↗

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

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

full page →fda approvals ↗

Dec 15, 2023approval972d agoFENTANYL-100 (FENTANYL) — FDA approvalZydus Therapeutics Inc

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

full page →fda approvals ↗

Dec 15, 2023approval972d agoFENTANYL-100 (FENTANYL) — FDA approvalZydus Therapeutics Inc

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

full page →fda approvals ↗

Dec 15, 2023approval972d agoACTIQ (FENTANYL CITRATE) — FDA approvalTeva Pharmaceuticals USA Inc

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

full page →fda approvals ↗

Dec 15, 2023approval972d agoBUTORPHANOL TARTRATE — FDA approvalBUTORPHANOL TARTRATE

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

full page →BUTORPHANOL TARTRATE →fda approvals ↗

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

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

full page →fda approvals ↗

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

Sponsor: GRANULES. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

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

Sponsor: GRANULES. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

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

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

full page →acetaminophen ER →fda approvals ↗

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

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

full page →acetaminophen ER →fda approvals ↗

Dec 15, 2023approval972d agoOXYMORPHONE HYDROCHLORIDE — FDA approvalOXYMORPHONE HYDROCHLORIDE

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

full page →OXYMORPHONE HYDROCHLORIDE →fda approvals ↗

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

Sponsor: QUAGEN. Form: TABLET. Route: ORAL

full page →MEPERIDINE HYDROCHLORIDE →fda approvals ↗

Dec 15, 2023approval972d agoMORPHINE SULFATE — FDA approvalKapanol

Sponsor: HIKMA. Form: SOLUTION. Route: ORAL

full page →Kapanol →fda approvals ↗

Dec 15, 2023approval972d agoMEPERIDINE HYDROCHLORIDE — FDA approvalMEPERIDINE HYDROCHLORIDE

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

full page →MEPERIDINE HYDROCHLORIDE →fda approvals ↗

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

Sponsor: HIKMA. Form: INJECTABLE. Route: INJECTION

full page →MEPERIDINE HYDROCHLORIDE →fda approvals ↗

Dec 15, 2023approval972d 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 15, 2023approval972d agoHYDROMORPHONE HYDROCHLORIDE — FDA approvalSpecGx LLC

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

full page →fda approvals ↗

Dec 15, 2023approval972d agoMORPHINE SULFATE — FDA approvalKapanol

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

full page →Kapanol →fda approvals ↗

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 ↗

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Week of Dec 11, 2023