Propranolol Hydrochloride

ANDA 71518, held by Superpharm. Propranolol Hydrochloride.

As of Nov 15, 2026, ANDA 71518 (Propranolol Hydrochloride), held by Superpharm, was first approved by FDA on Jun 8, 1988, with 4 approved supplements and 0 published complete response letters.

First approved: Jun 8, 1988
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Jun 8, 1988	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Propranolol Hydrochloride80MG · tablet;oral	Propranolol Hydrochloride	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Aug 17, 1990	Supplement 4Labeling	Approved	None posted
Mar 3, 1989	Supplement 3Labeling	Approved	None posted
Nov 2, 1988	Supplement 2Labeling	Approved	None posted
Jun 23, 1988	Supplement 1Labeling	Approved	None posted
Jun 8, 1988	Original application	Approved	None posted

Identifiers

Application: ANDA 71518
Drugs@FDA: Overview at FDA
Company: Superpharm

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