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FDA NDA · NDA020680

NORVIR

Sponsor: ABBOTT

APPLICATION
NDA020680
TYPE
NDA
ORIGINAL APPROVAL
1996-03-01
LATEST ACTION
1999-05-26
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

NORVIRDiscontinued
RITONAVIR 100MG · CAPSULE · ORAL

Approval history

1999-05-26Efficacy · Supplement 11 · priority — Review ↗AP
1999-04-29Labeling · Supplement 12 · priorityAP
1999-04-12Labeling · Supplement 13 · priorityAP
1999-04-09Labeling · Supplement 14 · priorityAP
1998-05-21Manufacturing (CMC) · Supplement 9 · priority — Review ↗AP
1998-02-12Labeling · Supplement 10 · priorityAP
1997-10-31Labeling · Supplement 8 · priorityAP
1997-09-12Manufacturing (CMC) · Supplement 7 · priorityAP
1997-07-11Manufacturing (CMC) · Supplement 6 · priorityAP
1997-01-08Labeling · Supplement 5 · priorityAP
1996-10-01Manufacturing (CMC) · Supplement 3 · priorityAP
1996-10-01Manufacturing (CMC) · Supplement 1 · priorityAP
1996-09-24Labeling · Supplement 4 · priorityAP
1996-03-01Type 3 - New Dosage Form · 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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