← FDA DRUG APPROVALS

FDA NDA · NDA019385

PERMAX

Sponsor: VALEANT PHARM INTL

APPLICATION
NDA019385
TYPE
NDA
ORIGINAL APPROVAL
1988-12-30
LATEST ACTION
2003-10-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

PERMAXDiscontinued
PERGOLIDE MESYLATE EQ 0.25MG BASE · TABLET · ORAL
PERMAXDiscontinued
PERGOLIDE MESYLATE EQ 1MG BASE · TABLET · ORAL
PERMAXDiscontinued
PERGOLIDE MESYLATE EQ 0.05MG BASE · TABLET · ORAL

Approval history

2003-10-02Labeling · Supplement 35 · priority — Letter ↗AP
2003-10-02Labeling · Supplement 31 · priority — Label ↗AP
2003-10-02Labeling · Supplement 30 · priority — Label ↗AP
2002-08-29Labeling · Supplement 28 · priority — Letter ↗AP
2002-05-17Manufacturing (CMC) · Supplement 32 · priorityAP
2000-12-07Manufacturing (CMC) · Supplement 29 · priorityAP
1999-10-06Labeling · Supplement 19 · priorityAP
1999-10-06Labeling · Supplement 17 · priorityAP
1999-10-06Labeling · Supplement 8 · priorityAP
1999-10-06Labeling · Supplement 4 · priorityAP
1999-10-06Labeling · Supplement 26 · priorityAP
1999-10-06Labeling · Supplement 16 · priorityAP
1999-10-06Labeling · Supplement 20 · priorityAP
1999-10-01Manufacturing (CMC) · Supplement 27 · priorityAP
1999-04-13Manufacturing (CMC) · Supplement 25 · priorityAP
1998-06-26Manufacturing (CMC) · Supplement 24 · priorityAP
1998-04-13Manufacturing (CMC) · Supplement 22 · priorityAP
1998-04-03Manufacturing (CMC) · Supplement 21 · priorityAP
1994-12-15Manufacturing (CMC) · Supplement 12 · priorityAP
1994-12-15Manufacturing (CMC) · Supplement 13 · priorityAP
1994-12-15Manufacturing (CMC) · Supplement 11 · priorityAP
1994-11-29Manufacturing (CMC) · Supplement 14 · priorityAP
1993-01-11Manufacturing (CMC) · Supplement 10 · priorityAP
1993-01-11Manufacturing (CMC) · Supplement 9 · priorityAP
1993-01-08Manufacturing (CMC) · Supplement 7 · priorityAP
1993-01-08Manufacturing (CMC) · Supplement 5 · priorityAP
1991-05-15Manufacturing (CMC) · Supplement 6 · priorityAP
1989-11-27Manufacturing (CMC) · Supplement 3 · priorityAP
1989-11-02Labeling · Supplement 2 · priorityAP
1989-03-17Manufacturing (CMC) · Supplement 1 · priorityAP
1988-12-30Type 1 - New Molecular Entity · Original · priority — Other Important Information from FDA ↗AP
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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