Optipranolol

NDA 19907, held by Bausch And Lomb. Metipranolol Hydrochloride.

As of Nov 13, 2026, NDA 19907 (Optipranolol), held by Bausch And Lomb, was first approved by FDA on Dec 29, 1989, with 19 approved supplements and 0 published complete response letters.

First approved: Dec 29, 1989
Review: Standard
Supplements approved: 19
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below

Date	Submission	Status	Documents
Dec 29, 1989	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Optipranolol0.3% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · solution/drops;ophthalmic	Metipranolol Hydrochloride	DiscontinuedReference drug

All 20 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Nov 21, 2006	Supplement 25Manufacturing · Standard review	Approved	Letter
Jul 26, 2002	Supplement 18Manufacturing · Standard review	Approved	None posted
Aug 30, 2001	Supplement 17Manufacturing · Standard review	Approved	None posted
Mar 8, 2001	Supplement 16Manufacturing · Standard review	Approved	None posted
Nov 6, 2000	Supplement 15Manufacturing · Standard review	Approved	None posted
Jul 18, 2000	Supplement 14Manufacturing · Standard review	Approved	None posted
May 17, 2000	Supplement 13Manufacturing · Standard review	Approved	None posted
Dec 13, 1999	Supplement 12Labeling · Standard review	Approved	None posted
Dec 13, 1999	Supplement 11Manufacturing · Standard review	Approved	None posted
May 19, 1999	Supplement 10Manufacturing · Standard review	Approved	None posted
Oct 21, 1998	Supplement 8Manufacturing · Standard review	Approved	None posted
May 20, 1998	Supplement 9Manufacturing · Standard review	Approved	None posted
Oct 3, 1997	Supplement 6Manufacturing · Standard review	Approved	None posted
Oct 3, 1997	Supplement 5Manufacturing · Standard review	Approved	None posted
Dec 19, 1996	Supplement 4Manufacturing · Standard review	Approved	None posted
Mar 21, 1996	Supplement 7Labeling · Standard review	Approved	None posted
May 11, 1995	Supplement 2Manufacturing · Standard review	Approved	None posted
May 8, 1995	Supplement 3Manufacturing · Standard review	Approved	None posted
Aug 15, 1994	Supplement 1Manufacturing · Standard review	Approved	None posted
Dec 29, 1989	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 19907
Drugs@FDA: Overview at FDA
Company: Bausch & Lomb

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