APPLICATION
ANDA089202
TYPE
ANDA
ORIGINAL APPROVAL
1986-02-18
LATEST ACTION
2006-08-11
ROUTE
INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
FOLIC ACIDPrescription
FOLIC ACID 5MG/ML · INJECTABLE · INJECTION
Approval history
2006-08-11Labeling · Supplement 20AP
2006-03-21Labeling · Supplement 15AP
2002-12-05Manufacturing (CMC) · Supplement 10AP
1995-01-20Manufacturing (CMC) · Supplement 8AP
1990-07-06Manufacturing (CMC) · Supplement 7AP
1988-12-08Manufacturing (CMC) · Supplement 6AP
1988-12-08Manufacturing (CMC) · Supplement 4AP
1988-12-08Manufacturing (CMC) · Supplement 5AP
1988-12-08Manufacturing (CMC) · Supplement 3AP
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
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.