Calendar

Week of Sep 23, 2019

Sep 23, 2019approval2510d agoMEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE (MEPERIDINE HYDROCHLORIDE) — FDA approvalHikma Pharmaceuticals Plc

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

full page →fda approvals ↗

Sep 23, 2019approval2510d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

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

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

Sep 23, 2019approval2510d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

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

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

Sep 23, 2019approval2510d agoVINCRISTINE SULFATE PFS (VINCRISTINE SULFATE) — FDA approvalVINCRISTINE SULFATE PFS

Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

full page →VINCRISTINE SULFATE PFS →fda approvals ↗

Sep 24, 2019approval2509d agoSIMPONI (GOLIMUMAB) — FDA approvalJanssen Biotech Inc

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

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Sep 25, 2019approval2508d agoLAMICTAL ODT (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

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

full page →LAMOTRIGINE →fda approvals ↗

Sep 25, 2019approval2508d agoLAMICTAL (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

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

full page →LAMOTRIGINE →fda approvals ↗

Sep 25, 2019approval2508d agoLAMICTAL CD (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

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

full page →LAMOTRIGINE →fda approvals ↗

Sep 25, 2019approval2508d agoLAMICTAL XR (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

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

full page →LAMOTRIGINE →fda approvals ↗

Sep 26, 2019approval2507d agoCOPIKTRA (DUVELISIB) — FDA approvalSecura Bio Inc

Sponsor: SECURA. Form: CAPSULE. Route: ORAL

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Sep 27, 2019approval2506d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

Sep 27, 2019approval2506d agoMEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE (MEPERIDINE HYDROCHLORIDE) — FDA approvalHikma Pharmaceuticals Plc

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

full page →fda approvals ↗

Sep 27, 2019approval2506d agoMETHYLPHENIDATE HYDROCHLORIDE — FDA approvalMETHYLPHENIDATE HYDROCHLORIDE

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

full page →METHYLPHENIDATE HYDROCHLORIDE →fda approvals ↗

Week of Sep 30, 2019

Sep 30, 2019approval2503d agoDESIPRAMINE HYDROCHLORIDE — FDA approvalDESIPRAMINE HYDROCHLORIDE

Sponsor: INGENUS PHARMS LLC. Form: TABLET. Route: ORAL

full page →DESIPRAMINE HYDROCHLORIDE →fda approvals ↗

Oct 2, 2019approval

Week of Oct 7, 2019

Oct 7, 2019approval2496d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗

Oct 7, 2019approval

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Week of Sep 23, 2019

Week of Sep 30, 2019

Week of Oct 7, 2019