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FDA NDA · NDA200179

STAXYN

Sponsor: BAYER HLTHCARE

APPLICATION
NDA200179
TYPE
NDA
ORIGINAL APPROVAL
2010-06-17
LATEST ACTION
2023-04-24
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Discontinued

Products

STAXYN · ReferenceDiscontinued
VARDENAFIL HYDROCHLORIDE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, ORALLY DISINTEGRATING · ORAL

Approval history

2023-04-24Labeling · Supplement 7 · standard — Label ↗AP
2017-08-16Labeling · Supplement 5 · standard — Label ↗AP
2017-08-02Efficacy · Supplement 4 · standard — Label ↗AP
2015-09-16Labeling · Supplement 3 · standard — Label ↗AP
2014-04-29Labeling · Supplement 2 · standard — Letter ↗AP
2013-08-02Efficacy · Supplement 1 · standard — Label ↗AP
2010-06-17Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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