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FDA NDA · NDA020666

ALBENDAZOLE

Sponsor: IMPAX LABS INC

APPLICATION
NDA020666
TYPE
NDA
ORIGINAL APPROVAL
1996-06-11
LATEST ACTION
2019-07-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ALBENZA · ReferenceDiscontinued
ALBENDAZOLE 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2019-07-11Labeling · Supplement 12 · standard — Label ↗AP
2018-10-31Labeling · Supplement 11 · standard — Letter ↗AP
2017-12-20Labeling · Supplement 10 · standard — Label ↗AP
2015-06-11Labeling · Supplement 9 · standard — Label ↗AP
2009-10-20Labeling · Supplement 5 · standard — Letter ↗AP
2009-10-20Labeling · Supplement 6 · standard — Letter ↗AP
2007-08-20Labeling · Supplement 4 · standard — Letter ↗AP
1996-06-11Type 1 - New Molecular Entity · Original · priority — Review ↗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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