← FDA DRUG APPROVALS

FDA NDA · NDA207975

VANTRELA ER

Sponsor: TEVA BRANDED PHARM

APPLICATION
NDA207975
TYPE
NDA
ORIGINAL APPROVAL
2017-01-17
LATEST ACTION
2017-05-26
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

VANTRELA ER · ReferenceDiscontinued
HYDROCODONE BITARTRATE 60MG · TABLET, EXTENDED RELEASE · ORAL
VANTRELA ER · ReferenceDiscontinued
HYDROCODONE BITARTRATE 30MG · TABLET, EXTENDED RELEASE · ORAL
VANTRELA ER · ReferenceDiscontinued
HYDROCODONE BITARTRATE 90MG · TABLET, EXTENDED RELEASE · ORAL
VANTRELA ER · ReferenceDiscontinued
HYDROCODONE BITARTRATE 45MG · TABLET, EXTENDED RELEASE · ORAL
VANTRELA ER · ReferenceDiscontinued
HYDROCODONE BITARTRATE 15MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2017-05-26REMS · Supplement 2 — Letter ↗AP
2017-01-17Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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