Propranolol Hydrochloride

ANDA 71791, held by Ani Pharms. Propranolol Hydrochloride.

As of Nov 15, 2026, ANDA 71791 (Propranolol Hydrochloride), held by Ani Pharms, was first approved by FDA on Jul 15, 1987, with 9 approved supplements and 0 published complete response letters.

First approved: Jul 15, 1987
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Jul 15, 1987	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Propranolol Hydrochloride60MG · tablet;oral	Propranolol Hydrochloride	Discontinued

All 10 submissions, including labeling and manufacturing supplements


Aug 31, 2001	Supplement 13Manufacturing	Approved	None posted
Nov 17, 1999	Supplement 11Labeling	Approved	None posted
Nov 10, 1999	Supplement 12Manufacturing	Approved	None posted
Feb 9, 1999	Supplement 10Labeling	Approved	None posted
Jun 4, 1992	Supplement 9Labeling	Approved	None posted
Feb 4, 1991	Supplement 8Labeling	Approved	None posted
Sep 10, 1990	Supplement 4Labeling	Approved	None posted
Jul 24, 1990	Supplement 3Labeling	Approved	None posted
Feb 28, 1990	Supplement 2Labeling	Approved	None posted
Jul 15, 1987	Original application	Approved	None posted

Identifiers

Application: ANDA 71791
Drugs@FDA: Overview at FDA
Company: ANI 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