Propranolol Hydrochloride

ANDA 70308, held by Duramed Pharms Barr. Propranolol Hydrochloride.

As of Nov 15, 2026, ANDA 70308 (Propranolol Hydrochloride), held by Duramed Pharms Barr, was first approved by FDA on Sep 9, 1985, with 3 approved supplements and 0 published complete response letters.

First approved: Sep 9, 1985
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Sep 9, 1985	Original application	Approved	None posted

Products

1 strengths and forms

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

All 4 submissions, including labeling and manufacturing supplements


Jan 23, 1990	Supplement 21Labeling	Approved	None posted
Sep 14, 1989	Supplement 20Labeling	Approved	None posted
Mar 27, 1989	Supplement 15Labeling	Approved	None posted
Sep 9, 1985	Original application	Approved	None posted

Identifiers

Application: ANDA 70308
Drugs@FDA: Overview at FDA
Company: Duramed Pharmaceuticals (Barr)

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