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FDA NDA · NDA021400

LEVITRA

Sponsor: BAYER HLTHCARE

APPLICATION
NDA021400
TYPE
NDA
ORIGINAL APPROVAL
2003-08-19
LATEST ACTION
2023-03-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

LEVITRA · ReferenceDiscontinued
VARDENAFIL HYDROCHLORIDE EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
LEVITRA · ReferenceDiscontinued
VARDENAFIL HYDROCHLORIDE EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
LEVITRA · ReferenceDiscontinued
VARDENAFIL HYDROCHLORIDE EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
LEVITRA · ReferenceDiscontinued
VARDENAFIL HYDROCHLORIDE EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2023-03-15Labeling · Supplement 23 · standard — Label ↗AP
2017-08-16Labeling · Supplement 20 · standard — Label ↗AP
2015-09-16Labeling · Supplement 19 · standard — Label ↗AP
2014-11-03Manufacturing (CMC) · Supplement 18 · standardAP
2014-04-29Labeling · Supplement 17 · standard — Label ↗AP
2013-08-02Efficacy · Supplement 16 · standard — Label ↗AP
2011-11-22Labeling · Supplement 13 · standard — Label ↗AP
2008-05-15Labeling · Supplement 12 · standard — Letter ↗AP
2008-03-19Labeling · Supplement 11 · standard — Letter ↗AP
2007-10-18Labeling · Supplement 10 · standard — Letter ↗AP
2007-04-06Labeling · Supplement 8 · standard — Letter ↗AP
2005-07-08Labeling · Supplement 4 · standard — Letter ↗AP
2005-05-13Labeling · Supplement 2 · standard — Label ↗AP
2003-08-19Type 1 - New Molecular Entity · Original · standard — Other Important Information from FDA ↗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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