Propranolol Hydrochloride

ANDA 70123, held by Schering. Propranolol Hydrochloride.

As of Nov 15, 2026, ANDA 70123 (Propranolol Hydrochloride), held by Schering, was first approved by FDA on Oct 29, 1986, with 1 approved supplement and 0 published complete response letters.

First approved: Oct 29, 1986
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Oct 29, 1986	Original application	Approved	None posted

Products

1 strengths and forms

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

All 2 submissions, including labeling and manufacturing supplements


Aug 11, 1988	Supplement 10Labeling	Approved	None posted
Oct 29, 1986	Original application	Approved	None posted

Identifiers

Application: ANDA 70123
Drugs@FDA: Overview at FDA
Company: Schering Corporation

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