Medihaler-Epi

NDA 10374, held by 3m. Epinephrine Bitartrate.

As of Nov 13, 2026, NDA 10374 (Medihaler-Epi), held by 3m, was first approved by FDA on Mar 9, 1956, with 12 approved supplements and 0 published complete response letters.

First approved: Mar 9, 1956
Supplements approved: 12
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Mar 9, 1956	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Medihaler-Epi0.3MG/INH · aerosol, metered;inhalation	Epinephrine Bitartrate	Discontinued

All 13 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Mar 13, 2009	Supplement 5Labeling	Approved	None posted
Mar 13, 2009	Supplement 6Labeling	Approved	None posted
Mar 13, 2009	Supplement 8Labeling	Approved	None posted
Mar 13, 2009	Supplement 11Labeling	Approved	None posted
Mar 13, 2009	Supplement 12Labeling	Approved	None posted
Mar 13, 2009	Supplement 13Labeling	Approved	None posted
Mar 13, 2009	Supplement 14Labeling	Approved	None posted
Mar 13, 2009	Supplement 18Labeling	Approved	None posted
Mar 13, 2009	Supplement 25Labeling · Standard review	Approved	None posted
Jan 14, 1994	Supplement 24Manufacturing	Approved	None posted
Sep 10, 1992	Supplement 20Labeling	Approved	None posted
Mar 20, 1989	Supplement 22Manufacturing	Approved	None posted
Mar 9, 1956	Original application	Approved	None posted

Identifiers

Application: NDA 10374
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