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pharmadog

Week of Oct 7, 2019

Oct 9, 2019approval2493d agoNALBUPHINE HYDROCHLORIDE — FDA approvalTrevi Therapeutics, Inc.

Sponsor: DR REDDYS. Form: SOLUTION. Route: INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

full page →fda approvals ↗

Oct 9, 2019approval2493d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: CHARTWELL. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Oct 9, 2019approval2493d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: CHARTWELL. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Oct 9, 2019approval2493d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: CHARTWELL. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Oct 9, 2019approval2493d agoMETHADONE HYDROCHLORIDE — FDA approvalMETHADONE HYDROCHLORIDE

Sponsor: HIKMA. Form: SOLUTION. Route: ORAL

full page →METHADONE HYDROCHLORIDE →fda approvals ↗

Oct 9, 2019approval2493d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

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

full page →tramadol hydrochloride ER →fda approvals ↗

Oct 9, 2019approval2493d agoBUTORPHANOL TARTRATE — FDA approvalBUTORPHANOL TARTRATE

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

full page →BUTORPHANOL TARTRATE →fda approvals ↗

Oct 9, 2019approval2493d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

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

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

Oct 9, 2019approval2493d agoADDYI (FLIBANSERIN) — FDA approvalSprout2 Inc

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

full page →fda approvals ↗

Oct 9, 2019approval2493d agoADDYI (FLIBANSERIN) — FDA approvalSprout2 Inc

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

full page →fda approvals ↗

Oct 9, 2019approval2493d agoLACTATED RINGER'S IN PLASTIC CONTAINER (CALCIUM CHLORIDE) — FDA approvalCALCIUM CHLORIDE 10%

Sponsor: BAXTER HLTHCARE. Form: INJECTABLE. Route: INJECTION

full page →CALCIUM CHLORIDE 10% →fda approvals ↗

Oct 9, 2019approval2493d agoLACTATED RINGER'S AND DEXTROSE 5% IN PLASTIC CONTAINER (CALCIUM CHLORIDE) — FDA approvalCALCIUM CHLORIDE 10%

Sponsor: BAXTER HLTHCARE. Form: INJECTABLE. Route: INJECTION

full page →CALCIUM CHLORIDE 10% →fda approvals ↗

Oct 9, 2019approval2493d agoPOTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER (CALCIUM CHLORIDE) — FDA approvalCALCIUM CHLORIDE 10%

Sponsor: BAXTER HLTHCARE. Form: INJECTABLE. Route: INJECTION

full page →CALCIUM CHLORIDE 10% →fda approvals ↗

Oct 9, 2019approval2493d agoCELECOXIB — FDA approvalCelebrex

Sponsor: LUPIN LTD. Form: CAPSULE. Route: ORAL

full page →Celebrex →fda approvals ↗

Oct 9, 2019approval2493d agoCELECOXIB — FDA approvalCelebrex

Sponsor: LUPIN LTD. Form: CAPSULE. Route: ORAL

full page →Celebrex →fda approvals ↗

Oct 9, 2019approval2493d agoCELECOXIB — FDA approvalCelebrex

Sponsor: LUPIN LTD. Form: CAPSULE. Route: ORAL

full page →Celebrex →fda approvals ↗

Oct 10, 2019approval2492d agoOXYMORPHONE HYDROCHLORIDE — FDA approvalOXYMORPHONE HYDROCHLORIDE

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

full page →OXYMORPHONE HYDROCHLORIDE →fda approvals ↗

Oct 10, 2019approval2492d agoOXYMORPHONE HYDROCHLORIDE — FDA approvalOXYMORPHONE HYDROCHLORIDE

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

full page →OXYMORPHONE HYDROCHLORIDE →fda approvals ↗

Oct 10, 2019approval2492d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗

Oct 10, 2019approval2492d agoNALBUPHINE HYDROCHLORIDE — FDA approvalNALBUPHINE HYDROCHLORIDE

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

full page →NALBUPHINE HYDROCHLORIDE →fda approvals ↗

Oct 10, 2019approval2492d agoNALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE (NALOXONE HYDROCHLORIDE) — FDA approvalLupin Ltd

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

full page →fda approvals ↗

Oct 10, 2019approval2492d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

full page →fda approvals ↗

Oct 10, 2019approval2492d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

full page →fda approvals ↗

Oct 10, 2019approval2492d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

full page →fda approvals ↗

Oct 10, 2019approval2492d agoNALBUPHINE HYDROCHLORIDE — FDA approvalNALBUPHINE HYDROCHLORIDE

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

full page →NALBUPHINE HYDROCHLORIDE →fda approvals ↗

Oct 10, 2019approval2492d agoHYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE) — FDA approvalStrides Pharma Inc

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

full page →fda approvals ↗

Oct 10, 2019approval2492d agoPIFELTRO (DORAVIRINE) — FDA approvaldoravirine

Sponsor: MSD MERCK CO. Form: TABLET. Route: ORAL

full page →doravirine →fda approvals ↗

Oct 10, 2019approval2492d agoDELSTRIGO (DORAVIRINE) — FDA approval(doravirine + lamivudine + tenofovir disoproxil fumarate)

Sponsor: MSD MERCK CO. Form: TABLET. Route: ORAL

full page →(doravirine + lamivudine + tenofovir disoproxil fumarate) →fda approvals ↗

Oct 11, 2019approval2491d agoXARELTO (RIVAROXABAN) — FDA approvalJanssen Therapeutics

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

full page →fda approvals ↗

Oct 11, 2019approval2491d agoMETHADONE HYDROCHLORIDE — FDA approvalMETHADONE HYDROCHLORIDE

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

full page →METHADONE HYDROCHLORIDE →fda approvals ↗

Oct 11, 2019approval2491d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

full page →fda approvals ↗

Oct 11, 2019approval2491d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

Oct 11, 2019approval2491d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

Oct 11, 2019approval2491d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

Sponsor: UPSHER SMITH LABS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Oct 11, 2019approval2491d agoTRAMADOL HYDROCHLORIDE — FDA approvalTrigen Laboratories Inc

Sponsor: SUN PHARM. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Oct 11, 2019approval2491d agoTRAMADOL HYDROCHLORIDE — FDA approvalTrigen Laboratories Inc

Sponsor: PH HEALTH. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Oct 11, 2019approval2491d agoTRAMADOL HYDROCHLORIDE — FDA approvalTrigen Laboratories Inc

Sponsor: SUN PHARM. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Oct 11, 2019approval2491d agoOXYMORPHONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: IMPAX LABS. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Oct 11, 2019approval2491d agoOXYCET (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

Oct 11, 2019approval2491d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

Oct 11, 2019approval2491d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

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

full page →tramadol hydrochloride ER →fda approvals ↗

Oct 11, 2019approval2491d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

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

full page →tramadol hydrochloride ER →fda approvals ↗

Oct 11, 2019approval2491d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

full page →fda approvals ↗

Oct 11, 2019approval2491d agoBUTORPHANOL TARTRATE PRESERVATIVE FREE (BUTORPHANOL TARTRATE) — FDA approvalBUTORPHANOL TARTRATE

Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

full page →BUTORPHANOL TARTRATE →fda approvals ↗

Oct 11, 2019approval2491d agoLEVORPHANOL TARTRATE — FDA approvalLEVORPHANOL TARTRATE

Sponsor: HIKMA. Form: TABLET. Route: ORAL

full page →LEVORPHANOL TARTRATE →fda approvals ↗

Oct 11, 2019approval2491d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

full page →fda approvals ↗

Oct 11, 2019approval2491d agoMEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE (MEPERIDINE HYDROCHLORIDE) — FDA approvalHikma Pharmaceuticals Plc

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

full page →fda approvals ↗

Oct 11, 2019approval2491d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

Oct 11, 2019approval2491d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

full page →fda approvals ↗

Oct 11, 2019approval2491d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

full page →fda approvals ↗

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Week of Oct 7, 2019