← FDA DRUG APPROVALS

FDA ANDA · ANDA080600

FOLIC ACID

Sponsor: HIKMA PHARMS

APPLICATION
ANDA080600
TYPE
ANDA
ORIGINAL APPROVAL
1972-03-31
LATEST ACTION
2000-02-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

FOLIC ACIDDiscontinued
FOLIC ACID 1MG · TABLET · ORAL

Approval history

2000-02-17Manufacturing (CMC) · Supplement 31AP
1999-05-13Manufacturing (CMC) · Supplement 29AP
1999-05-13Manufacturing (CMC) · Supplement 30AP
1998-10-01Manufacturing (CMC) · Supplement 28AP
1997-12-10Labeling · Supplement 27AP
1997-12-10Manufacturing (CMC) · Supplement 25AP
1997-12-10Manufacturing (CMC) · Supplement 26AP
1997-06-19Manufacturing (CMC) · Supplement 24AP
1995-04-24Labeling · Supplement 23AP
1994-07-29Manufacturing (CMC) · Supplement 21AP
1994-07-29Labeling · Supplement 22AP
1993-07-29Manufacturing (CMC) · Supplement 20AP
1993-06-28Labeling · Supplement 19AP
1993-06-28Labeling · Supplement 40AP
1989-07-17Labeling · Supplement 14AP
1987-10-01Manufacturing (CMC) · Supplement 13AP
1987-08-24Manufacturing (CMC) · Supplement 12AP
1984-05-31Manufacturing (CMC) · Supplement 10AP
1983-03-17Manufacturing (CMC) · Supplement 6AP
1972-03-31Original — 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 →