Ambenyl

NDA 9319, held by Forest Labs. Bromodiphenhydramine Hydrochloride; Codeine Phosphate.

As of Nov 13, 2026, NDA 9319 (Ambenyl), held by Forest Labs, was first approved by FDA on Apr 28, 1954, with 15 approved supplements and 0 published complete response letters.

First approved: Apr 28, 1954
Review: Standard
Supplements approved: 15
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 16 submissions below


Jan 10, 1984	Supplement 18Efficacy (new indication or use)	Approved	None posted
Apr 28, 1954	Original applicationNew combination · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Ambenyl12.5MG/5ML;10MG/5ML · syrup;oral	Bromodiphenhydramine Hydrochloride; Codeine Phosphate	Discontinued

All 16 submissions, including labeling and manufacturing supplements


Dec 7, 2007	Supplement 16Labeling	Approved	None posted
Dec 7, 2007	Supplement 14Labeling	Approved	None posted
Dec 7, 2007	Supplement 13Labeling	Approved	None posted
Dec 7, 2007	Supplement 12Labeling	Approved	None posted
Dec 7, 2007	Supplement 11Labeling	Approved	None posted
Dec 7, 2007	Supplement 9Labeling	Approved	None posted
Dec 7, 2007	Supplement 8Labeling	Approved	None posted
Dec 7, 2007	Supplement 6Labeling	Approved	None posted
Nov 10, 1993	Supplement 24Labeling	Approved	None posted
Apr 14, 1993	Supplement 28Manufacturing · Standard review	Approved	None posted
Sep 22, 1989	Supplement 25Manufacturing · Standard review	Approved	None posted
Aug 26, 1988	Supplement 23Manufacturing · Standard review	Approved	None posted
Feb 27, 1986	Supplement 21Labeling	Approved	None posted
Jan 10, 1984	Supplement 18Efficacy (new indication or use)	Approved	None posted
Jan 10, 1984	Supplement 17Manufacturing · Standard review	Approved	None posted
Apr 28, 1954	Original applicationNew combination · Standard review	Approved	None posted

Identifiers

Application: NDA 9319
Drugs@FDA: Overview at FDA
Company: Forest 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