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FDA NDA · NDA205208

DESVENLAFAXINE

Sponsor: TEVA PHARMS USA

APPLICATION
NDA205208
TYPE
NDA
ORIGINAL APPROVAL
2013-10-11
LATEST ACTION
2014-07-18
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

DESVENLAFAXINEDiscontinued
DESVENLAFAXINE FUMARATE EQ 50MG BASE · TABLET, EXTENDED RELEASE · ORAL
DESVENLAFAXINEDiscontinued
DESVENLAFAXINE FUMARATE EQ 100MG BASE · TABLET, EXTENDED RELEASE · ORAL

Approval history

2014-07-18Labeling · Supplement 1 · 901 required — Label ↗AP
2013-10-11Type 5 - New Formulation or New Manufacturer · Original · standard — Medication Guide ↗AP
VIEW ON DRUGS@FDA ↗

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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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