Propranolol Hydrochloride

ANDA 75826, held by Fresenius Kabi USA. Propranolol Hydrochloride.

First approved: Aug 31, 2001
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Aug 31, 2001	Original application	Approved	Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Propranolol Hydrochloride1MG/ML · injectable;injection	Propranolol Hydrochloride	Rx

All 6 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Nov 7, 2007	Supplement 7Labeling	Approved	None posted
Apr 3, 2002	Supplement 4Labeling	Approved	None posted
Feb 19, 2002	Supplement 1Manufacturing	Approved	None posted
Feb 19, 2002	Supplement 2Manufacturing	Approved	None posted
Feb 19, 2002	Supplement 3Manufacturing	Approved	None posted
Aug 31, 2001	Original application	Approved	Letter

Identifiers

Application: ANDA 75826
Drugs@FDA: Overview at FDA
Company: Fresenius Kabi USA

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters