Propranolol Hydrochloride

ANDA 72501, held by Inwood Labs. Propranolol Hydrochloride.

As of Nov 15, 2026, ANDA 72501 (Propranolol Hydrochloride), held by Inwood Labs, was first approved by FDA on Apr 11, 1989, with 8 approved supplements and 0 published complete response letters.

First approved: Apr 11, 1989
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Apr 11, 1989	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Propranolol Hydrochloride120MG · capsule, extended release;oral	Propranolol Hydrochloride	Discontinued

All 9 submissions, including labeling and manufacturing supplements


Sep 30, 1998	Supplement 9Labeling	Approved	None posted
Jun 16, 1998	Supplement 8Labeling	Approved	None posted
Mar 9, 1998	Supplement 7Manufacturing	Approved	None posted
Jan 26, 1998	Supplement 6Labeling	Approved	None posted
Jan 31, 1997	Supplement 5Manufacturing	Approved	None posted
Apr 23, 1993	Supplement 4Labeling	Approved	None posted
Feb 22, 1993	Supplement 3Manufacturing	Approved	None posted
Nov 20, 1990	Supplement 1Manufacturing	Approved	None posted
Apr 11, 1989	Original application	Approved	None posted

Identifiers

Application: ANDA 72501
Drugs@FDA: Overview at FDA
Company: Inwood 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