Propranolol Hydrochloride

ANDA 78065, held by Anda Repository. Propranolol Hydrochloride.

As of Nov 15, 2026, ANDA 78065 (Propranolol Hydrochloride), held by Anda Repository, was first approved by FDA on Jan 26, 2007, with 1 approved supplement and 0 published complete response letters.

First approved: Jan 26, 2007
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
Jan 26, 2007	Original application	Approved	Letter Label

Products

4 strengths and forms


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

All 2 submissions, including labeling and manufacturing supplements


Apr 13, 2015	Supplement 4Labeling	Approved	None posted
Jan 26, 2007	Original application	Approved	Letter Label

Identifiers

Application: ANDA 78065
Drugs@FDA: Overview at FDA
Company: ANDA Repository

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