← FDA DRUG APPROVALS

FDA NDA · NDA020677

ZAGAM

Sponsor: MYLAN

APPLICATION
NDA020677
TYPE
NDA
ORIGINAL APPROVAL
1996-12-19
LATEST ACTION
2003-04-04
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ZAGAMDiscontinued
SPARFLOXACIN 200MG · TABLET · ORAL

Approval history

2003-04-04Labeling · Supplement 6 · standard — Label ↗AP
2002-10-02Labeling · Supplement 4 · standard — Letter ↗AP
2001-05-11Manufacturing (CMC) · Supplement 5 · standardAP
1999-12-10Manufacturing (CMC) · Supplement 3 · standard — Review ↗AP
1999-10-19Labeling · Supplement 2 · standard — Review ↗AP
1999-10-19Labeling · Supplement 1 · standard — Review ↗AP
1996-12-19Type 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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