ANDA 80132, held by Purepac Pharm. Isoniazid.
As of Nov 15, 2026, ANDA 80132 (Isoniazid), held by Purepac Pharm, was not approved, with 3 approved supplements and 0 published complete response letters.
| Jan 9, 1985 | Supplement 18Manufacturing | Approved | None posted |
| Jul 14, 1982 | Supplement 15Manufacturing | Approved | None posted |
| Mar 4, 1982 | Supplement 13Manufacturing | 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
