Calendar

pharmadog

Sep 23, 2019approval2535d agoVINCRISTINE SULFATE PFS (VINCRISTINE SULFATE) — FDA approvalVINCRISTINE SULFATE PFS

Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

full page →VINCRISTINE SULFATE PFS →fda approvals ↗

Sep 24, 2019approval2534d agoSIMPONI (GOLIMUMAB) — FDA approvalJanssen Biotech Inc

Sponsor: CENTOCOR ORTHO BIOTECH INC. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Sep 25, 2019approval2533d agoLAMICTAL ODT (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗

Sep 25, 2019approval2533d agoLAMICTAL (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

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

full page →LAMOTRIGINE →fda approvals ↗

Sep 25, 2019approval2533d agoLAMICTAL CD (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, FOR SUSPENSION. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗

Sep 25, 2019approval2533d agoLAMICTAL XR (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗

Sep 26, 2019approval2532d agoCOPIKTRA (DUVELISIB) — FDA approvalSecura Bio Inc

Sponsor: SECURA. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Sep 27, 2019approval2531d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

Sep 27, 2019approval2531d agoMEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE (MEPERIDINE HYDROCHLORIDE) — FDA approvalHikma Pharmaceuticals Plc

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

full page →fda approvals ↗

Sep 27, 2019approval2531d agoMETHYLPHENIDATE HYDROCHLORIDE — FDA approvalMETHYLPHENIDATE HYDROCHLORIDE

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

full page →METHYLPHENIDATE HYDROCHLORIDE →fda approvals ↗

Week of Oct 7, 2019

Oct 7, 2019approval2521d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗

Oct 7, 2019approval2521d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: ALVOGEN. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Oct 7, 2019approval2521d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

Oct 7, 2019approval2521d agoALFENTA (ALFENTANIL HYDROCHLORIDE) — FDA approvalalfentanil hydrochloride

Sponsor: RISING. Form: INJECTABLE. Route: INJECTION

full page →alfentanil hydrochloride →fda approvals ↗

Oct 7, 2019approval2521d agoPERCOCET (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

Sponsor: OZANTRI. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Oct 7, 2019approval2521d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

Sponsor: GENUS. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

Oct 7, 2019approval2521d agoNUBAIN (NALBUPHINE HYDROCHLORIDE) — FDA approvalTrevi Therapeutics, Inc.

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

full page →fda approvals ↗

Oct 7, 2019approval2521d agoACTIQ (FENTANYL CITRATE) — FDA approvalTeva Pharmaceuticals USA Inc

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

full page →fda approvals ↗

Oct 7, 2019approval2521d agoBUTORPHANOL TARTRATE — FDA approvalBUTORPHANOL TARTRATE

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

full page →BUTORPHANOL TARTRATE →fda approvals ↗

Oct 7, 2019approval2521d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalEon Labs Inc

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

full page →fda approvals ↗

Oct 7, 2019approval2521d agoDEMEROL (MEPERIDINE HYDROCHLORIDE) — FDA approvalMEPERIDINE HYDROCHLORIDE

Sponsor: QUAGEN. Form: TABLET. Route: ORAL

full page →MEPERIDINE HYDROCHLORIDE →fda approvals ↗

Oct 7, 2019approval2521d agoMORPHINE SULFATE — FDA approvalKapanol

Sponsor: HIKMA. Form: SOLUTION. Route: ORAL

full page →Kapanol →fda approvals ↗

Oct 7, 2019approval2521d agoMEPERGAN (MEPERIDINE HYDROCHLORIDE) — FDA approvalMEPERIDINE HYDROCHLORIDE

Sponsor: HIKMA. Form: INJECTABLE. Route: INJECTION

full page →MEPERIDINE HYDROCHLORIDE →fda approvals ↗

Oct 7, 2019approval2521d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: TEVA PHARMS USA. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗

Oct 7, 2019approval2521d agoMORPHINE SULFATE — FDA approvalKapanol

Sponsor: HIKMA. Form: TABLET. Route: ORAL

full page →Kapanol →fda approvals ↗

Oct 7, 2019approval2521d agoMORPHINE SULFATE — FDA approvalKapanol

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

full page →Kapanol →fda approvals ↗

Oct 7, 2019approval2521d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalEon Labs Inc

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

full page →fda approvals ↗

Oct 7, 2019approval2521d agoBELBUCA (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalIGC Pharma, Inc.

Sponsor: BDSI. Form: FILM. Route: BUCCAL

full page →fda approvals ↗

Oct 7, 2019approval2521d agoFIORICET W/ CODEINE (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

full page →fda approvals ↗

Oct 7, 2019approval2521d agoDEMEROL (MEPERIDINE HYDROCHLORIDE) — FDA approvalMEPERIDINE HYDROCHLORIDE

Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

full page →MEPERIDINE HYDROCHLORIDE →fda approvals ↗

Oct 7, 2019approval2521d agoOXYCODONE HYDROCHLORIDE AND IBUPROFEN (IBUPROFEN) — FDA approvalMidol

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

full page →Midol →fda approvals ↗

Oct 7, 2019approval2521d agoOXYCONTIN (OXYCODONE HYDROCHLORIDE) — FDA approvalOXYCODONE HYDROCHLORIDE

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

full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗

Oct 7, 2019approval2521d agoPROBUPHINE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalIGC Pharma, Inc.

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

full page →fda approvals ↗

Oct 7, 2019approval2521d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

Oct 7, 2019approval2521d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

Oct 7, 2019approval2521d agoDILAUDID-HP (HYDROMORPHONE HYDROCHLORIDE) — FDA approvalHYDROMORPHONE HYDROCHLORIDE

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

full page →HYDROMORPHONE HYDROCHLORIDE →fda approvals ↗

Oct 7, 2019approval2521d agoPERCODAN (ASPIRIN) — FDA approvalEndo Pharmaceuticals Inc

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

full page →fda approvals ↗

Oct 7, 2019approval2521d agoDURAMORPH PF (MORPHINE SULFATE) — FDA approvalKapanol

Sponsor: HIKMA. Form: INJECTABLE. Route: INJECTION

full page →Kapanol →fda approvals ↗

Oct 7, 2019approval2521d agoROXYBOND (OXYCODONE HYDROCHLORIDE) — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗

Oct 7, 2019approval2521d agoCODEINE SULFATE — FDA approvalcodeine

Sponsor: HIKMA. Form: SOLUTION. Route: ORAL

full page →codeine →fda approvals ↗

Oct 7, 2019approval2521d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: HIKMA. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

Week of Sep 23, 2019

Week of Sep 30, 2019

Week of Oct 7, 2019