Propranolol Hydrochloride

ANDA 70666, held by Chartwell Rx. Propranolol Hydrochloride.

As of Nov 15, 2026, ANDA 70666 (Propranolol Hydrochloride), held by Chartwell Rx, was first approved by FDA on Oct 10, 1986, with 14 approved supplements and 0 published complete response letters.

First approved: Oct 10, 1986
Supplements approved: 14
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Oct 10, 1986	Original application	Approved	None posted

Products

1 strengths and forms

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

All 15 submissions, including labeling and manufacturing supplements


May 9, 2001	Supplement 15Manufacturing	Approved	None posted
May 18, 1995	Supplement 14Manufacturing	Approved	None posted
May 22, 1992	Supplement 13Labeling	Approved	None posted
Jul 10, 1989	Supplement 12Labeling	Approved	None posted
Dec 23, 1988	Supplement 3Manufacturing	Approved	None posted
Dec 23, 1988	Supplement 4Manufacturing	Approved	None posted
Dec 23, 1988	Supplement 5Labeling	Approved	None posted
Dec 23, 1988	Supplement 9Manufacturing	Approved	None posted
Dec 14, 1988	Supplement 10Manufacturing	Approved	None posted
Nov 29, 1988	Supplement 11Labeling	Approved	None posted
Feb 11, 1988	Supplement 7Manufacturing	Approved	None posted
Jul 31, 1987	Supplement 6Labeling	Approved	None posted
Mar 13, 1987	Supplement 2Labeling	Approved	None posted
Feb 5, 1987	Supplement 1Manufacturing	Approved	None posted
Oct 10, 1986	Original application	Approved	None posted

Identifiers

Application: ANDA 70666
Drugs@FDA: Overview at FDA
Company: Chartwell RX

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