ANDA 75287, held by Watson Labs. Pemoline.
As of Nov 13, 2026, ANDA 75287 (Pemoline), held by Watson Labs, was first approved by FDA on Sep 18, 2000, with 3 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 18, 2000 | Original application | Approved |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 27, 2002 | Supplement 3Manufacturing | Approved | None posted |
| Jun 13, 2001 | Supplement 1Manufacturing | Approved | None posted |
| Jun 13, 2001 | Supplement 2Labeling | Approved | None posted |
| Sep 18, 2000 | Original application | Approved |
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
