ANDA 84575, held by Impax Labs. Aminophylline.
As of Nov 15, 2026, ANDA 84575 (Aminophylline), held by Impax Labs, was first approved by FDA on Mar 19, 1976, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 19, 1976 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Aminophylline200MG ยท tablet, delayed release;oral | Aminophylline | Discontinued |
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
