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pharmadog

Week of Oct 7, 2019

Oct 7, 2019approval2495d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

Oct 7, 2019approval2495d agoDILAUDID-HP (HYDROMORPHONE HYDROCHLORIDE) — FDA approvalHYDROMORPHONE HYDROCHLORIDE

Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: INJECTION

full page →HYDROMORPHONE HYDROCHLORIDE →fda approvals ↗

Oct 7, 2019approval2495d agoPERCODAN (ASPIRIN) — FDA approvalEndo Pharmaceuticals Inc

Sponsor: ENDO OPERATIONS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Oct 7, 2019approval2495d agoDURAMORPH PF (MORPHINE SULFATE) — FDA approvalKapanol

Sponsor: HIKMA. Form: INJECTABLE. Route: INJECTION

full page →Kapanol →fda approvals ↗

Oct 7, 2019approval2495d agoROXYBOND (OXYCODONE HYDROCHLORIDE) — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗

Oct 7, 2019approval2495d agoCODEINE SULFATE — FDA approvalcodeine

Sponsor: HIKMA. Form: SOLUTION. Route: ORAL

full page →codeine →fda approvals ↗

Oct 7, 2019approval2495d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: HIKMA. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

Oct 7, 2019approval2495d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: HIKMA. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

Oct 7, 2019approval2495d agoNUCYNTA (TAPENTADOL HYDROCHLORIDE) — FDA approvaltapentadol hydrochloride ER

Sponsor: COLLEGIUM PHARM INC. Form: TABLET. Route: ORAL

full page →tapentadol hydrochloride ER →fda approvals ↗

Oct 7, 2019approval2495d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalEon Labs Inc

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

full page →fda approvals ↗

Oct 7, 2019approval2495d agoDILAUDID (HYDROMORPHONE HYDROCHLORIDE) — FDA approvalSpecGx LLC

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

full page →fda approvals ↗

Oct 7, 2019approval2495d agoFENTORA (FENTANYL CITRATE) — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: CEPHALON. Form: TABLET. Route: BUCCAL, SUBLINGUAL

full page →fda approvals ↗

Oct 7, 2019approval2495d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

Oct 7, 2019approval2495d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

Oct 7, 2019approval2495d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

Oct 7, 2019approval2495d agoDILAUDID (HYDROMORPHONE HYDROCHLORIDE) — FDA approvalSpecGx LLC

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

full page →fda approvals ↗

Oct 7, 2019approval2495d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

Oct 7, 2019approval2495d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: PAI HOLDINGS. Form: SOLUTION. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Oct 7, 2019approval2495d agoSUBLIMAZE PRESERVATIVE FREE (FENTANYL CITRATE) — FDA approvalEffentora

Sponsor: RISING. Form: INJECTABLE. Route: INJECTION

full page →Effentora →fda approvals ↗

Oct 7, 2019approval2495d agoULTIVA (REMIFENTANIL HYDROCHLORIDE) — FDA approvalremifentanil hydrochloride

Sponsor: MYLAN INSTITUTIONAL. Form: INJECTABLE. Route: INJECTION

full page →remifentanil hydrochloride →fda approvals ↗

Oct 7, 2019approval2495d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

Oct 7, 2019approval2495d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

Oct 7, 2019approval2495d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalIGC Pharma, Inc.

Sponsor: PHARMOBEDIENT. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗

Oct 7, 2019approval2495d agoSUBLOCADE (BUPRENORPHINE) — FDA approvalbuprenorphine LA

Sponsor: INDIVIOR. Form: SOLUTION, EXTENDED RELEASE. Route: SUBCUTANEOUS

full page →buprenorphine LA →fda approvals ↗

Oct 7, 2019approval2495d agoDSUVIA (SUFENTANIL CITRATE) — FDA approvalVertical Pharmaceuticals LLC

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

full page →fda approvals ↗

Oct 7, 2019approval2495d agoCONZIP (TRAMADOL HYDROCHLORIDE) — FDA approvalTrigen Laboratories Inc

Sponsor: CIPHER PHARMS INC. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Oct 7, 2019approval2495d agoNUCYNTA (TAPENTADOL HYDROCHLORIDE) — FDA approvaltapentadol hydrochloride ER

Sponsor: COLLEGIUM PHARM INC. Form: SOLUTION. Route: ORAL

full page →tapentadol hydrochloride ER →fda approvals ↗

Oct 7, 2019approval2495d agoMETHADONE HYDROCHLORIDE — FDA approvalMETHADONE HYDROCHLORIDE

Sponsor: MYLAN INSTITUTIONAL. Form: INJECTABLE. Route: INJECTION

full page →METHADONE HYDROCHLORIDE →fda approvals ↗

Oct 7, 2019approval2495d agoSYNALGOS-DC (ASPIRIN) — FDA approvalBUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE

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

full page →BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE →fda approvals ↗

Oct 7, 2019approval2495d agoMETHADOSE (METHADONE HYDROCHLORIDE) — FDA approvalMETHADONE HYDROCHLORIDE

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

full page →METHADONE HYDROCHLORIDE →fda approvals ↗

Oct 7, 2019approval2495d agoCODEINE SULFATE — FDA approvalcodeine

Sponsor: HIKMA. Form: TABLET. Route: ORAL

full page →codeine →fda approvals ↗

Oct 7, 2019approval2495d agoBUTRANS (BUPRENORPHINE) — FDA approvalBUTRANS

Sponsor: PURDUE PHARMA LP. Form: FILM, EXTENDED RELEASE. Route: TRANSDERMAL

full page →BUTRANS →fda approvals ↗

Oct 7, 2019approval2495d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: CHARTWELL. Form: SOLUTION. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Oct 7, 2019approval2495d agoSUBOXONE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: INDIVIOR. Form: FILM. Route: BUCCAL, SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

Oct 7, 2019approval2495d agoHYDROMORPHONE HYDROCHLORIDE — FDA approvalHYDROMORPHONE HYDROCHLORIDE

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

full page →HYDROMORPHONE HYDROCHLORIDE →fda approvals ↗

Oct 7, 2019approval2495d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

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

full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗

Oct 7, 2019approval2495d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

Oct 7, 2019approval2495d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

Oct 7, 2019approval2495d agoACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

Sponsor: PHARMOBEDIENT. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Oct 7, 2019approval2495d agoXTAMPZA ER (OXYCODONE) — FDA approvaloxycodone ER

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

full page →oxycodone ER →fda approvals ↗

Oct 7, 2019approval2495d agoMORPHINE SULFATE — FDA approvalKapanol

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

full page →Kapanol →fda approvals ↗

Oct 7, 2019approval2495d agoZUBSOLV (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalEdenbridge Pharmaceuticals LLC

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

full page →fda approvals ↗

Oct 7, 2019approval2495d agoROXICODONE (OXYCODONE HYDROCHLORIDE) — FDA approvalOXYCODONE HYDROCHLORIDE

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

full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗

Oct 7, 2019approval2495d agoFENTANYL CITRATE — FDA approvalEffentora

Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

full page →Effentora →fda approvals ↗

Oct 7, 2019approval2495d agoMETHADONE HYDROCHLORIDE — FDA approvalMETHADONE HYDROCHLORIDE

Sponsor: HIKMA. Form: TABLET, FOR SUSPENSION. Route: ORAL

full page →METHADONE HYDROCHLORIDE →fda approvals ↗

Oct 7, 2019approval2495d agoMS CONTIN (MORPHINE SULFATE) — FDA approvalKapanol

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

full page →Kapanol →fda approvals ↗

Oct 7, 2019approval2495d agoSUFENTA PRESERVATIVE FREE (SUFENTANIL CITRATE) — FDA approvalsufentanil citrate

Sponsor: RISING. Form: INJECTABLE. Route: INJECTION

full page →sufentanil citrate →fda approvals ↗

Oct 7, 2019approval2495d agoNUCYNTA ER (TAPENTADOL HYDROCHLORIDE) — FDA approvaltapentadol hydrochloride ER

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

full page →tapentadol hydrochloride ER →fda approvals ↗

Oct 7, 2019approval2495d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

Sponsor: GENUS LIFESCIENCES. Form: CAPSULE. Route: ORAL

full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗

Oct 7, 2019approval2495d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

Sponsor: GENUS LIFESCIENCES. Form: SOLUTION. Route: ORAL

full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗

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Week of Oct 7, 2019