← FDA DRUG APPROVALS

FDA NDA · NDA005897

FOLVITE

Sponsor: WYETH PHARMS INC

APPLICATION
NDA005897
TYPE
NDA
ORIGINAL APPROVAL
1947-06-05
LATEST ACTION
1984-09-10
ROUTE
INJECTION, ORAL
DOSAGE FORM
INJECTABLE, TABLET
MARKETING STATUS
Discontinued

Products

FOLVITE · ReferenceDiscontinued
FOLIC ACID 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
FOLVITEDiscontinued
FOLIC ACID 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

1984-09-10Manufacturing (CMC) · Supplement 26AP
1984-05-03Manufacturing (CMC) · Supplement 24AP
1984-04-20Manufacturing (CMC) · Supplement 25AP
1981-03-09Labeling · Supplement 22AP
1979-12-13Manufacturing (CMC) · Supplement 19AP
1979-10-26Labeling · Supplement 18AP
1979-10-26Manufacturing (CMC) · Supplement 14AP
1979-10-26Manufacturing (CMC) · Supplement 20AP
1979-10-26Manufacturing (CMC) · Supplement 21AP
1979-01-10Manufacturing (CMC) · Supplement 16AP
1979-01-10Manufacturing (CMC) · Supplement 17AP
1976-05-13REMS · Supplement 12AP
1976-05-13Manufacturing (CMC) · Supplement 13AP
1976-05-13REMS · Supplement 11AP
1947-06-05UNKNOWN · Original · unknownAP
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 →