← FDA DRUG APPROVALS

FDA NDA · NDA020828

FORTOVASE

Sponsor: HOFFMANN LA ROCHE

APPLICATION
NDA020828
TYPE
NDA
ORIGINAL APPROVAL
1997-11-07
LATEST ACTION
2005-09-08
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

FORTOVASE · ReferenceDiscontinued
SAQUINAVIR 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL

Approval history

2005-09-08Labeling · Supplement 19 · priority — Review ↗AP
2005-09-08Labeling · Supplement 20 · priority — Review ↗AP
2003-12-24Efficacy · Supplement 15 · priority — Label ↗AP
2002-07-02Labeling · Supplement 10 · priority — Letter ↗AP
2002-03-28Manufacturing (CMC) · Supplement 11 · priorityAP
2000-11-13Labeling · Supplement 8 · priorityAP
2000-09-22Manufacturing (CMC) · Supplement 9 · priorityAP
1999-09-08Manufacturing (CMC) · Supplement 7 · priorityAP
1999-03-18Manufacturing (CMC) · Supplement 6 · priority — Review ↗AP
1999-02-12Manufacturing (CMC) · Supplement 4 · priorityAP
1998-12-04Manufacturing (CMC) · Supplement 5 · priorityAP
1998-09-09Manufacturing (CMC) · Supplement 2 · priorityAP
1998-08-05Labeling · Supplement 1 · priorityAP
1997-11-07Type 3 - New Dosage Form · Original · priority — 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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