Propranolol Hydrochloride

ANDA 70120, held by Schering. Propranolol Hydrochloride.

As of Nov 15, 2026, ANDA 70120 (Propranolol Hydrochloride), held by Schering, was first approved by FDA on Aug 6, 1985, with 1 approved supplement and 0 published complete response letters.

First approved: Aug 6, 1985
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
Aug 6, 1985	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Propranolol Hydrochloride10MG · tablet;oral	Propranolol Hydrochloride	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Aug 22, 1988	Supplement 20Labeling	Approved	None posted
Aug 6, 1985	Original application	Approved	None posted

Identifiers

Application: ANDA 70120
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