Propranolol Hydrochloride

ANDA 70125, held by Dava Pharms Inc. Propranolol Hydrochloride.

As of Nov 15, 2026, ANDA 70125 (Propranolol Hydrochloride), held by Dava Pharms Inc, was first approved by FDA on Jul 30, 1985, with 4 approved supplements and 0 published complete response letters.

First approved: Jul 30, 1985
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
Jul 30, 1985	Original application	Approved	None posted

Products

1 strengths and forms

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

All 5 submissions, including labeling and manufacturing supplements


Jun 5, 1991	Supplement 12Labeling	Approved	None posted
Mar 21, 1991	Supplement 11Labeling	Approved	None posted
May 17, 1989	Supplement 10Labeling	Approved	None posted
Oct 25, 1988	Supplement 9Labeling	Approved	None posted
Jul 30, 1985	Original application	Approved	None posted

Identifiers

Application: ANDA 70125
Drugs@FDA: Overview at FDA
Company: DAVA Pharmaceuticals

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