Propranolol Hydrochloride

ANDA 78311, held by Upsher Smith Labs. Propranolol Hydrochloride.

As of Nov 15, 2026, ANDA 78311 (Propranolol Hydrochloride), held by Upsher Smith Labs, was first approved by FDA on Mar 6, 2009, with 1 approved supplement and 0 published complete response letters.

First approved: Mar 6, 2009
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Mar 6, 2009	Original application	Approved	None posted

Products

4 strengths and forms


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

All 2 submissions, including labeling and manufacturing supplements


Apr 27, 2015	Supplement 4Labeling	Approved	None posted
Mar 6, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 78311
Drugs@FDA: Overview at FDA
Company: Upsher-Smith Laboratories

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