Propranolol Hydrochloride

ANDA 70548, held by Watson Labs Teva. Propranolol Hydrochloride.

As of Nov 15, 2026, ANDA 70548 (Propranolol Hydrochloride), held by Watson Labs Teva, was first approved by FDA on Jul 10, 1986, with 13 approved supplements and 0 published complete response letters.

First approved: Jul 10, 1986
Supplements approved: 13
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Jul 10, 1986	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Propranolol Hydrochloride10MG · tablet;oral	Propranolol Hydrochloride	Discontinued

All 14 submissions, including labeling and manufacturing supplements


Aug 31, 2001	Supplement 16Manufacturing	Approved	None posted
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
Dec 22, 1988	Supplement 4Labeling	Approved	None posted
Aug 10, 1987	Supplement 3Labeling	Approved	None posted
Mar 3, 1987	Supplement 1Labeling	Approved	None posted
Feb 5, 1987	Supplement 2Manufacturing	Approved	None posted
Jul 10, 1986	Original application	Approved	None posted

Identifiers

Application: ANDA 70548
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