Propranolol Hydrochloride

ANDA 70549, held by Watson Labs Teva. Propranolol Hydrochloride.

As of Nov 15, 2026, ANDA 70549 (Propranolol Hydrochloride), held by Watson Labs Teva, was first approved by FDA on Apr 11, 1986, with 10 approved supplements and 0 published complete response letters.

First approved: Apr 11, 1986
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Apr 11, 1986	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Propranolol Hydrochloride20MG · tablet;oral	Propranolol Hydrochloride	Discontinued

All 11 submissions, including labeling and manufacturing supplements


Nov 17, 1999	Supplement 15Labeling	Approved	None posted
Nov 10, 1999	Supplement 14Manufacturing	Approved	None posted
Feb 9, 1999	Supplement 13Labeling	Approved	None posted
Jun 4, 1992	Supplement 12Labeling	Approved	None posted
Feb 4, 1991	Supplement 11Labeling	Approved	None posted
Sep 10, 1990	Supplement 7Labeling	Approved	None posted
Jul 26, 1990	Supplement 6Labeling	Approved	None posted
Feb 28, 1990	Supplement 5Labeling	Approved	None posted
Nov 29, 1988	Supplement 4Labeling	Approved	None posted
Feb 20, 1987	Supplement 1Manufacturing	Approved	None posted
Apr 11, 1986	Original application	Approved	None posted

Identifiers

Application: ANDA 70549
Drugs@FDA: Overview at FDA
Company: Watson Labs Teva

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