← FDA DRUG APPROVALS

FDA NDA · NDA022104

VENLAFAXINE HYDROCHLORIDE

Sponsor: OSMOTICA PHARM US

APPLICATION
NDA022104
TYPE
NDA
ORIGINAL APPROVAL
2008-05-20
LATEST ACTION
2023-08-18
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

VENLAFAXINE HYDROCHLORIDE · ReferencePrescription
VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE · TABLET, EXTENDED RELEASE · ORAL
VENLAFAXINE HYDROCHLORIDE · ReferencePrescription
VENLAFAXINE HYDROCHLORIDE EQ 150MG BASE · TABLET, EXTENDED RELEASE · ORAL
VENLAFAXINE HYDROCHLORIDE · ReferencePrescription
VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE · TABLET, EXTENDED RELEASE · ORAL
VENLAFAXINE HYDROCHLORIDE · ReferencePrescription
VENLAFAXINE HYDROCHLORIDE EQ 225MG BASE · TABLET, EXTENDED RELEASE · ORAL

Approval history

2023-08-18Labeling · Supplement 23 · standard — Label ↗AP
2021-09-20Labeling · Supplement 21 · standard — Letter ↗AP
2017-12-19Labeling · Supplement 16 · 901 required — Label ↗AP
2017-01-04Labeling · Supplement 15 · 901 required — Label ↗AP
2016-12-14Manufacturing (CMC) · Supplement 13 · standardAP
2016-06-21Manufacturing (CMC) · Supplement 11 · standardAP
2016-03-24Manufacturing (CMC) · Supplement 12 · standardAP
2014-07-18Labeling · Supplement 10 · 901 required — Label ↗AP
2012-12-11Labeling · Supplement 9 · standard — Label ↗AP
2012-07-31REMS · Supplement 7 — Letter ↗AP
2012-05-02Labeling · Supplement 8 · standard — Label ↗AP
2009-02-27Manufacturing (CMC) · Supplement 2 — Label ↗AP
2009-01-30Labeling · Supplement 3 · standard — Letter ↗AP
2008-05-20Type 3 - New Dosage Form · Original · standard — Other Important Information from FDA ↗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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