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FDA NDA · NDA204683

KHEDEZLA

Sponsor: OSMOTICA PHARM CORP

APPLICATION
NDA204683
TYPE
NDA
ORIGINAL APPROVAL
2013-07-10
LATEST ACTION
2021-09-20
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

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

Approval history

2021-09-20Labeling · Supplement 7 · standard — Letter ↗AP
2019-01-29Labeling · Supplement 6 · standard — Label ↗AP
2017-12-19Labeling · Supplement 5 · 901 required — Label ↗AP
2017-01-04Labeling · Supplement 4 · 901 required — Label ↗AP
2016-09-06Labeling · Supplement 3 · 901 required — Label ↗AP
2014-07-16Labeling · Supplement 2 · 901 required — Label ↗AP
2013-10-01Labeling · Supplement 1 · standard — Label ↗AP
2013-07-10Type 5 - New Formulation or New Manufacturer · Original · standard — Summary Review ↗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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