Propranolol Hydrochloride

ANDA 70219, held by Vintage Pharms. Propranolol Hydrochloride.

As of Nov 15, 2026, ANDA 70219 (Propranolol Hydrochloride), held by Vintage Pharms, was first approved by FDA on Aug 1, 1986, with 4 approved supplements and 0 published complete response letters.

First approved: Aug 1, 1986
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Aug 1, 1986	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Propranolol Hydrochloride40MG · tablet;oral	Propranolol Hydrochloride	Rx

All 5 submissions, including labeling and manufacturing supplements


Jan 27, 2012	Supplement 22Labeling	Approved	None posted
Nov 13, 1991	Supplement 20Labeling	Approved	None posted
Feb 13, 1991	Supplement 19Labeling	Approved	None posted
Sep 6, 1989	Supplement 18Labeling	Approved	None posted
Aug 1, 1986	Original application	Approved	None posted

Identifiers

Application: ANDA 70219
Drugs@FDA: Overview at FDA
Company: Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals

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