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FDA NDA · NDA204150

DESVENLAFAXINE

Sponsor: ALEMBIC PHARMS LTD

APPLICATION
NDA204150
TYPE
NDA
ORIGINAL APPROVAL
2013-03-04
LATEST ACTION
2023-08-18
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

DESVENLAFAXINE · ReferencePrescription
DESVENLAFAXINE 50MG · TABLET, EXTENDED RELEASE · ORAL
DESVENLAFAXINE · ReferencePrescription
DESVENLAFAXINE 100MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2023-08-18Labeling · Supplement 20 · standard — Label ↗AP
2021-09-20Labeling · Supplement 18 · standard — Label ↗AP
2019-10-29Labeling · Supplement 10 · standard — Letter ↗AP
2017-12-19Labeling · Supplement 7 · 901 required — Label ↗AP
2017-01-04Labeling · Supplement 5 · 901 required — Label ↗AP
2016-09-09Labeling · Supplement 4 · 901 required — Letter ↗AP
2015-05-15Labeling · Supplement 3 · standard — Label ↗AP
2014-07-07Labeling · Supplement 2 · 901 required — Label ↗AP
2014-07-07Labeling · Supplement 1 · standard — Label ↗AP
2013-03-04Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
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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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