Promethazine Hydrochloride And Dextromethorphan Hydrobromide

NDA 11265, held by Ani Pharms. Dextromethorphan Hydrobromide; Promethazine Hydrochloride.

As of Nov 13, 2026, NDA 11265 (Promethazine Hydrochloride And Dextromethorphan Hydrobromide), held by Ani Pharms, was first approved by FDA on Dec 3, 1957, with 16 approved supplements and 0 published complete response letters.

First approved: Dec 3, 1957
Review: Standard
Supplements approved: 16
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below


Aug 11, 1988	Supplement 19Efficacy (new indication or use)	Approved	None posted
Apr 2, 1984	Supplement 13Efficacy (new indication or use)	Approved	None posted
Dec 3, 1957	Original applicationNew combination · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Promethazine Hydrochloride And Dextromethorphan Hydrobromide15MG/5ML;6.25MG/5ML · syrup;oral	Dextromethorphan Hydrobromide; Promethazine Hydrochloride	RxReference drug

All 17 submissions, including labeling and manufacturing supplements


Sep 16, 2009	Supplement 31Labeling · Standard review	Approved	Letter
Apr 2, 2008	Supplement 29Manufacturing	Approved	Label Letter
Jan 16, 2004	Supplement 28Labeling · Standard review	Approved	Letter
Feb 23, 2001	Supplement 27Labeling · Standard review	Approved	Review
May 6, 1998	Supplement 25Manufacturing · Standard review	Approved	None posted
Feb 27, 1996	Supplement 24Labeling · Standard review	Approved	None posted
Mar 30, 1992	Supplement 23Manufacturing · Standard review	Approved	None posted
Nov 16, 1989	Supplement 22Manufacturing · Standard review	Approved	None posted
Aug 11, 1988	Supplement 19Efficacy (new indication or use)	Approved	None posted
Jun 30, 1988	Supplement 21Manufacturing · Standard review	Approved	None posted
May 29, 1986	Supplement 15Manufacturing · Standard review	Approved	None posted
Sep 16, 1985	Supplement 18Labeling	Approved	None posted
Jul 31, 1985	Supplement 16Manufacturing · Standard review	Approved	None posted
Apr 11, 1984	Supplement 14Labeling	Approved	None posted
Apr 2, 1984	Supplement 13Efficacy (new indication or use)	Approved	None posted
Apr 2, 1984	Supplement 12Manufacturing · Standard review	Approved	None posted
Dec 3, 1957	Original applicationNew combination · Standard review	Approved	None posted

Identifiers

Application: NDA 11265
Drugs@FDA: Overview at FDA
Company: ANI Pharmaceuticals

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