Propranolol Hydrochloride Intensol

ANDA 71388, held by Roxane. Propranolol Hydrochloride.

As of Nov 15, 2026, ANDA 71388 (Propranolol Hydrochloride Intensol), held by Roxane, was first approved by FDA on May 15, 1987, with 11 approved supplements and 0 published complete response letters.

First approved: May 15, 1987
Supplements approved: 11
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

Date	Submission	Status	Documents
May 15, 1987	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Propranolol Hydrochloride Intensol80MG/ML · concentrate;oral	Propranolol Hydrochloride	Discontinued

All 12 submissions, including labeling and manufacturing supplements


Aug 1, 2001	Supplement 15Labeling	Approved	None posted
Feb 20, 2001	Supplement 14Manufacturing	Approved	None posted
Feb 20, 2001	Supplement 13Manufacturing	Approved	None posted
Aug 28, 1996	Supplement 10Manufacturing	Approved	None posted
Jan 5, 1994	Supplement 9Labeling	Approved	None posted
May 16, 1991	Supplement 8Labeling	Approved	None posted
Oct 9, 1990	Supplement 7Labeling	Approved	None posted
Mar 9, 1990	Supplement 6Labeling	Approved	None posted
Feb 28, 1990	Supplement 4Manufacturing	Approved	None posted
Jan 16, 1990	Supplement 5Labeling	Approved	None posted
Dec 21, 1988	Supplement 2Manufacturing	Approved	None posted
May 15, 1987	Original application	Approved	None posted

Identifiers

Application: ANDA 71388
Drugs@FDA: Overview at FDA
Company: Roxane Laboratories

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