← FDA DRUG APPROVALS

FDA NDA · NDA021039

AGENERASE

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APPLICATION
NDA021039
TYPE
NDA
ORIGINAL APPROVAL
1999-04-15
LATEST ACTION
2005-11-04
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

AGENERASE · ReferenceDiscontinued
AMPRENAVIR 15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · ORAL

Approval history

2005-11-04Labeling · Supplement 17 — Letter ↗AP
2004-02-12Labeling · Supplement 16 — Letter ↗AP
2002-12-24Manufacturing (CMC) · Supplement 15AP
2002-10-02Labeling · Supplement 13 — Label ↗AP
2002-10-02Labeling · Supplement 14 — Label ↗AP
2002-08-02Labeling · Supplement 10 — Label ↗AP
2002-02-05Labeling · Supplement 12 — Letter ↗AP
2002-02-05Efficacy · Supplement 9 — Letter ↗AP
2001-05-11Efficacy · Supplement 6 — Label ↗AP
2001-05-09Labeling · Supplement 8AP
2000-12-19Labeling · Supplement 5AP
2000-04-28Labeling · Supplement 2AP
2000-04-24Labeling · Supplement 3AP
1999-12-22Manufacturing (CMC) · Supplement 4AP
1999-09-22Labeling · Supplement 1AP
1999-04-15Type 3 - New Dosage Form · Original — Letter ↗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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