ANDA 83982, held by Sun Pharm Industries. Propylthiouracil.
As of Nov 14, 2026, ANDA 83982 (Propylthiouracil), held by Sun Pharm Industries, was first approved by FDA on May 6, 1974, with 16 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 6, 1974 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Propylthiouracil50MG ยท tablet;oral | Propylthiouracil | Discontinued |
| Dec 1, 1998 | Supplement 46Manufacturing | Approved | None posted |
| Dec 23, 1994 | Supplement 45Manufacturing | Approved | None posted |
| Oct 11, 1994 | Supplement 44Manufacturing | Approved | None posted |
| Apr 3, 1992 | Supplement 43Manufacturing | Approved | None posted |
| Apr 3, 1992 | Supplement 41Manufacturing | Approved | None posted |
| Jun 5, 1990 | Supplement 40Labeling | Approved | None posted |
| Oct 28, 1988 | Supplement 39Labeling | Approved | None posted |
| Feb 22, 1988 | Supplement 38Manufacturing | Approved | None posted |
| Feb 22, 1988 | Supplement 37Manufacturing | Approved | None posted |
| Feb 22, 1988 | Supplement 36Manufacturing | Approved | None posted |
| Feb 22, 1988 | Supplement 35Manufacturing | Approved | None posted |
| Apr 6, 1987 | Supplement 34Manufacturing | Approved | None posted |
| Sep 22, 1986 | Supplement 33Manufacturing | Approved | None posted |
| Oct 8, 1985 | Supplement 32Manufacturing | Approved | None posted |
| Feb 28, 1983 | Supplement 28Manufacturing | Approved | None posted |
| Feb 28, 1983 | Supplement 27Manufacturing | Approved | None posted |
| May 6, 1974 | 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
