ANDA 90321, held by Zydus Pharms USA Inc. Propranolol Hydrochloride.
As of Nov 15, 2026, ANDA 90321 (Propranolol Hydrochloride), held by Zydus Pharms USA Inc, was first approved by FDA on Mar 25, 2011, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 25, 2011 | Original application | Approved | None posted |
| Propranolol Hydrochloride60MG · capsule, extended release;oral | Propranolol Hydrochloride | Rx |
| Propranolol Hydrochloride80MG · capsule, extended release;oral | Propranolol Hydrochloride | Rx |
| Propranolol Hydrochloride120MG · capsule, extended release;oral | Propranolol Hydrochloride | Rx |
| Propranolol Hydrochloride160MG · capsule, extended release;oral | Propranolol Hydrochloride | Rx |
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
