← FDA DRUG APPROVALS

FDA NDA · NDA020716

VICOPROFEN

Sponsor: ABBVIE

APPLICATION
NDA020716
TYPE
NDA
ORIGINAL APPROVAL
1997-09-23
LATEST ACTION
2016-12-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

VICOPROFEN · ReferenceDiscontinued
HYDROCODONE BITARTRATE 7.5MG, IBUPROFEN 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2016-12-16Labeling · Supplement 16 · standard — Letter ↗AP
2016-12-16Labeling · Supplement 14 · standard — Letter ↗AP
2016-12-16Labeling · Supplement 12 · standard — Letter ↗AP
2016-12-16Labeling · Supplement 15 · standard — Letter ↗AP
2016-12-16Labeling · Supplement 13 · standard — Letter ↗AP
2012-08-27Labeling · Supplement 11 · standard — Letter ↗AP
2008-07-25Labeling · Supplement 10 · standard — Letter ↗AP
2006-10-26Labeling · Supplement 8 · standard — Letter ↗AP
2002-12-02Manufacturing (CMC) · Supplement 7 · standardAP
2001-12-13Manufacturing (CMC) · Supplement 6 · standardAP
2001-02-13Manufacturing (CMC) · Supplement 5 · standardAP
2000-03-14Manufacturing (CMC) · Supplement 4 · standardAP
1998-06-17Manufacturing (CMC) · Supplement 1 · standardAP
1997-09-23Type 4 - New Combination · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →