Propranolol Hydrochloride

ANDA 78022, held by Chartwell Rx. Propranolol Hydrochloride.

As of Nov 15, 2026, ANDA 78022 (Propranolol Hydrochloride), held by Chartwell Rx, was first approved by FDA on Feb 15, 2007, with 2 approved supplements and 0 published complete response letters.

First approved: Feb 15, 2007
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Feb 15, 2007	Original application	Approved	Letter

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 3 submissions, including labeling and manufacturing supplements


Aug 23, 2024	Supplement 8Labeling · Standard review	Approved	None posted
Jun 13, 2015	Supplement 5Labeling · Standard review	Approved	None posted
Feb 15, 2007	Original application	Approved	Letter

Identifiers

Application: ANDA 78022
Drugs@FDA: Overview at FDA
Company: Chartwell 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