Duo-Medihaler

NDA 13296, held by 3m. Isoproterenol Hydrochloride; Phenylephrine Bitartrate.

As of Nov 13, 2026, NDA 13296 (Duo-Medihaler), held by 3m, was first approved by FDA on Aug 20, 1973, with 5 approved supplements and 0 published complete response letters.

First approved: Aug 20, 1973
Review: Standard
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 20, 1973	Original applicationNew combination · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Duo-Medihaler0.16MG/INH;0.24MG/INH · aerosol, metered;inhalation	Isoproterenol Hydrochloride; Phenylephrine Bitartrate	Discontinued

All 6 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Mar 13, 2009	Supplement 8Labeling	Approved	None posted
Feb 23, 1994	Supplement 13Labeling · Standard review	Approved	None posted
Feb 27, 1987	Supplement 11Labeling	Approved	None posted
May 21, 1984	Supplement 10Manufacturing · Standard review	Approved	None posted
Mar 5, 1982	Supplement 9Manufacturing · Standard review	Approved	None posted
Aug 20, 1973	Original applicationNew combination · Standard review	Approved	None posted

Identifiers

Application: NDA 13296
Drugs@FDA: Overview at FDA
Company: 3M

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