← FDA DRUG APPROVALS

FDA NDA · NDA019982

ZEBETA

Sponsor: TEVA BRANDED PHARM

APPLICATION
NDA019982
TYPE
NDA
ORIGINAL APPROVAL
1992-07-31
LATEST ACTION
2014-06-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ZEBETA · ReferenceDiscontinued
BISOPROLOL FUMARATE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
ZEBETA · ReferenceDiscontinued
BISOPROLOL FUMARATE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2014-06-12Manufacturing (CMC) · Supplement 18 · standardAP
2013-08-28Manufacturing (CMC) · Supplement 17 · standardAP
2011-02-03Labeling · Supplement 16 · unknown — Label ↗AP
2007-09-25Labeling · Supplement 14 · standard — Letter ↗AP
2003-01-24Labeling · Supplement 10 · standard — Letter ↗AP
2000-04-04Labeling · Supplement 7 · standardAP
1998-06-23Manufacturing (CMC) · Supplement 5 · standard — Review ↗AP
1998-02-19Manufacturing (CMC) · Supplement 6 · standard — Review ↗AP
1997-01-14Manufacturing (CMC) · Supplement 4 · standard — Review ↗AP
1995-05-30Labeling · Supplement 3 · standard — Review ↗AP
1993-06-11Manufacturing (CMC) · Supplement 1 · standard — Review ↗AP
1992-07-31Type 1 - New Molecular Entity · Original · standard — 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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