← FDA DRUG APPROVALS

FDA ANDA · ANDA075659

AFEDITAB CR

Sponsor: WATSON LABS

APPLICATION
ANDA075659
TYPE
ANDA
ORIGINAL APPROVAL
2001-10-26
LATEST ACTION
2005-05-03
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

AFEDITAB CRDiscontinued
NIFEDIPINE 60MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2005-05-03Labeling · Supplement 8AP
2002-06-18Manufacturing (CMC) · Supplement 4AP
2002-04-05Manufacturing (CMC) · Supplement 1AP
2002-03-15Manufacturing (CMC) · Supplement 3AP
2001-10-26Original — Letter ↗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 →