NDA 5897, held by Wyeth Pharms Inc. Folic Acid.
As of Nov 13, 2026, NDA 5897 (Folvite), held by Wyeth Pharms Inc, was first approved by FDA on Jun 5, 1947, with 14 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 5, 1947 | Original application | Approved | None posted |
| Folvite1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Folic Acid | Discontinued |
| Folvite5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Folic Acid | DiscontinuedReference drug |
| Sep 10, 1984 | Supplement 26Manufacturing | Approved | None posted |
| May 3, 1984 | Supplement 24Manufacturing | Approved | None posted |
| Apr 20, 1984 | Supplement 25Manufacturing | Approved | None posted |
| Mar 9, 1981 | Supplement 22Labeling | Approved | None posted |
| Dec 13, 1979 | Supplement 19Manufacturing | Approved | None posted |
| Oct 26, 1979 | Supplement 21Manufacturing | Approved | None posted |
| Oct 26, 1979 | Supplement 20Manufacturing | Approved | None posted |
| Oct 26, 1979 | Supplement 18Labeling | Approved | None posted |
| Oct 26, 1979 | Supplement 14Manufacturing | Approved | None posted |
| Jan 10, 1979 | Supplement 17Manufacturing | Approved | None posted |
| Jan 10, 1979 | Supplement 16Manufacturing | Approved | None posted |
| May 13, 1976 | Supplement 13Manufacturing | Approved | None posted |
| May 13, 1976 | Supplement 12REMS | Approved | None posted |
| May 13, 1976 | Supplement 11REMS | Approved | None posted |
| Jun 5, 1947 | Original application | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
