ANDA 84563, held by Valeant Pharm Intl. Aminophylline.
As of Nov 15, 2026, ANDA 84563 (Aminophylline), held by Valeant Pharm Intl, was first approved by FDA on May 28, 1976, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 28, 1976 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Aminophylline200MG ยท tablet;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
