Propranolol Hydrochloride

ANDA 70518, held by Roxane. Propranolol Hydrochloride.

As of Nov 15, 2026, ANDA 70518 (Propranolol Hydrochloride), held by Roxane, was first approved by FDA on Jul 7, 1986, with 5 approved supplements and 0 published complete response letters.

First approved: Jul 7, 1986
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Jul 7, 1986	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Propranolol Hydrochloride40MG · tablet;oral	Propranolol Hydrochloride	Discontinued

All 6 submissions, including labeling and manufacturing supplements


May 16, 1991	Supplement 12Labeling	Approved	None posted
Oct 9, 1990	Supplement 11Labeling	Approved	None posted
Mar 9, 1990	Supplement 10Labeling	Approved	None posted
Jan 8, 1990	Supplement 8Labeling	Approved	None posted
Sep 8, 1989	Supplement 9Labeling	Approved	None posted
Jul 7, 1986	Original application	Approved	None posted

Identifiers

Application: ANDA 70518
Drugs@FDA: Overview at FDA
Company: Roxane 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