← FDA DRUG APPROVALS

FDA NDA · NDA021007

AGENERASE

Sponsor: GLAXOSMITHKLINE

APPLICATION
NDA021007
TYPE
NDA
ORIGINAL APPROVAL
1999-04-15
LATEST ACTION
2005-11-04
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

AGENERASEDiscontinued
AMPRENAVIR 150MG · CAPSULE · ORAL
AGENERASEDiscontinued
AMPRENAVIR 50MG · CAPSULE · ORAL

Approval history

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