Propranolol Hydrochloride

NDA 16419, held by Baxter Hlthcare Corp. Propranolol Hydrochloride.

As of Nov 13, 2026, NDA 16419 (Propranolol Hydrochloride), held by Baxter Hlthcare Corp, was first approved by FDA on Nov 13, 1967, with 17 approved supplements and 0 published complete response letters.

First approved: Nov 13, 1967
Review: Priority
Supplements approved: 17
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below

Date	Submission	Status	Documents
Nov 13, 1967	Original applicationNew dosage form · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Propranolol Hydrochloride1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Propranolol Hydrochloride	DiscontinuedReference drug

All 18 submissions, including labeling and manufacturing supplements


Apr 1, 2008	Supplement 29Labeling · Standard review	Approved	Label Letter
Jul 24, 2006	Supplement 26Labeling · Standard review	Approved	Letter
Feb 6, 2002	Supplement 24Labeling · Standard review	Approved	None posted
Dec 7, 2001	Supplement 25Manufacturing · Priority review	Approved	None posted
Feb 14, 2001	Supplement 23Manufacturing · Priority review	Approved	None posted
Aug 22, 1999	Supplement 22Labeling · Standard review	Approved	None posted
Nov 7, 1997	Supplement 21Labeling · Standard review	Approved	None posted
Feb 14, 1990	Supplement 20Labeling	Approved	None posted
Dec 6, 1988	Supplement 19Manufacturing · Priority review	Approved	None posted
Aug 12, 1988	Supplement 18Manufacturing · Priority review	Approved	None posted
Jun 18, 1985	Supplement 17Manufacturing · Priority review	Approved	None posted
Jun 23, 1982	Supplement 15Manufacturing · Priority review	Approved	None posted
Jun 23, 1982	Supplement 16Manufacturing · Priority review	Approved	None posted
Mar 12, 1981	Supplement 14Manufacturing · Priority review	Approved	None posted
Jan 17, 1979	Supplement 12Labeling	Approved	None posted
Dec 12, 1978	Supplement 13Labeling	Approved	None posted
Aug 21, 1978	Supplement 9Labeling	Approved	None posted
Nov 13, 1967	Original applicationNew dosage form · Priority review	Approved	None posted

Identifiers

Application: NDA 16419
Drugs@FDA: Overview at FDA
Company: Baxter Healthcare

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