ANDA 204349, held by Lupin. Propranolol Hydrochloride.
As of Nov 15, 2026, ANDA 204349 (Propranolol Hydrochloride), held by Lupin, was first approved by FDA on Jan 12, 2024, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 12, 2024 | Original application | Approved | None posted |
| Propranolol Hydrochloride60MG · capsule, extended release;oral | Propranolol Hydrochloride | Discontinued |
| Propranolol Hydrochloride80MG · capsule, extended release;oral | Propranolol Hydrochloride | Discontinued |
| Propranolol Hydrochloride120MG · capsule, extended release;oral | Propranolol Hydrochloride | Discontinued |
| Propranolol Hydrochloride160MG · capsule, extended release;oral | Propranolol Hydrochloride | 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
