Propranolol Hydrochloride

ANDA 70178, held by Watson Labs. Propranolol Hydrochloride.

As of Nov 15, 2026, ANDA 70178 (Propranolol Hydrochloride), held by Watson Labs, was first approved by FDA on May 13, 1986, with 21 approved supplements and 0 published complete response letters.

First approved: May 13, 1986
Supplements approved: 21
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 22 submissions below

Date	Submission	Status	Documents
May 13, 1986	Original application	Approved	None posted

Products

2 strengths and forms


Propranolol Hydrochloride80MG · tablet;oral	Propranolol Hydrochloride	Rx
Propranolol Hydrochloride60MG · tablet;oral	Propranolol Hydrochloride	Discontinued

All 22 submissions, including labeling and manufacturing supplements


May 18, 2015	Supplement 52Labeling · Standard review	Approved	None posted
Jul 14, 2008	Supplement 39Labeling	Approved	None posted
May 3, 2005	Supplement 32Labeling	Approved	None posted
Jun 27, 2002	Supplement 28Labeling	Approved	None posted
Apr 25, 2001	Supplement 27Manufacturing	Approved	None posted
Oct 28, 1999	Supplement 26Labeling	Approved	None posted
Sep 8, 1998	Supplement 24Labeling	Approved	None posted
Feb 18, 1993	Supplement 22Labeling	Approved	None posted
Aug 7, 1991	Supplement 15Manufacturing	Approved	None posted
Jun 21, 1991	Supplement 19Labeling	Approved	None posted
Mar 21, 1991	Supplement 18Labeling	Approved	None posted
Jan 28, 1991	Supplement 16Manufacturing	Approved	None posted
Jun 29, 1990	Supplement 14Manufacturing	Approved	None posted
May 8, 1989	Supplement 13Labeling	Approved	None posted
May 8, 1989	Supplement 12Manufacturing	Approved	None posted
May 8, 1989	Supplement 11Labeling	Approved	None posted
Jun 3, 1988	Supplement 10Manufacturing	Approved	None posted
Jun 3, 1988	Supplement 9Manufacturing	Approved	None posted
Mar 25, 1988	Supplement 7Manufacturing	Approved	None posted
Dec 22, 1987	Supplement 6Manufacturing	Approved	None posted
Dec 22, 1987	Supplement 5Manufacturing	Approved	None posted
May 13, 1986	Original application	Approved	None posted

Identifiers

Application: ANDA 70178
Drugs@FDA: Overview at FDA
Company: Watson 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