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FOLIC ACID 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION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FOLIC ACID 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL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