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FDA NDA · NDA204308

EPANED KIT

Sponsor: AZURITY

APPLICATION
NDA204308
TYPE
NDA
ORIGINAL APPROVAL
2013-08-13
LATEST ACTION
2017-07-28
ROUTE
ORAL
DOSAGE FORM
FOR SOLUTION
MARKETING STATUS
Discontinued

Products

EPANED KIT · ReferenceDiscontinued
ENALAPRIL MALEATE 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · FOR SOLUTION · ORAL

Approval history

2017-07-28Labeling · Supplement 7 · standard — Label ↗AP
2017-03-22Labeling · Supplement 6 · standard — Label ↗AP
2016-01-29Labeling · Supplement 5 · standard — Label ↗AP
2015-12-28Manufacturing (CMC) · Supplement 4 · standardAP
2014-09-04Efficacy · Supplement 3 · standard — Label ↗AP
2014-09-04Efficacy · Supplement 2 · standard — Letter ↗AP
2014-02-03Manufacturing (CMC) · Supplement 1 · standardAP
2013-08-13Type 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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