← FDA DRUG APPROVALS

FDA NDA · NDA020720

REZULIN

Sponsor: PFIZER PHARMS

APPLICATION
NDA020720
TYPE
NDA
ORIGINAL APPROVAL
1997-01-29
LATEST ACTION
1999-06-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

REZULINDiscontinued
TROGLITAZONE 400MG · TABLET · ORAL
REZULINDiscontinued
TROGLITAZONE 300MG · TABLET · ORAL
REZULINDiscontinued
TROGLITAZONE 200MG · TABLET · ORAL

Approval history

1999-06-16Labeling · Supplement 14 · priority — Review ↗AP
1999-06-16Efficacy · Supplement 12 · priority — Review ↗AP
1998-11-02Manufacturing (CMC) · Supplement 8 · priorityAP
1998-07-22Labeling · Supplement 10 · priorityAP
1997-12-15Labeling · Supplement 7 · priority — Review ↗AP
1997-11-19Labeling · Supplement 6 · priority — Review ↗AP
1997-08-04Manufacturing (CMC) · Supplement 5 · priority — Review ↗AP
1997-08-04Efficacy · Supplement 3 · priority — Review ↗AP
1997-08-04Efficacy · Supplement 2 · priority — Review ↗AP
1997-04-04Labeling · Supplement 1 · priority — Review ↗AP
1997-04-04Labeling · Supplement 4 · priority — Review ↗AP
1997-01-29Type 1 - New Molecular Entity · Original · priorityAP
VIEW ON DRUGS@FDA ↗

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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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