Sus-Phrine Sulfite Free

NDA 7942, held by Forest Labs. Epinephrine.

As of Nov 15, 2026, NDA 7942 (Sus-Phrine Sulfite Free), held by Forest Labs, was first approved by FDA on Jun 8, 1951, with 14 approved supplements and 0 published complete response letters.

First approved: Jun 8, 1951
Review: Standard
Supplements approved: 14
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below


Dec 7, 2007	Supplement 1Efficacy (new indication or use)	Approved	None posted
Jun 8, 1951	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

2 strengths and forms


Sus-Phrine Sulfite Free5MG/ML · injectable;injection	Epinephrine	Discontinued
Sus-Phrine Sulfite Free1.5MG/AMP · injectable;injection	Epinephrine	Discontinued

All 15 submissions, including labeling and manufacturing supplements


Dec 7, 2007	Supplement 1Efficacy (new indication or use)	Approved	None posted
Dec 7, 2007	Supplement 9Labeling	Approved	None posted
Dec 7, 2007	Supplement 12Labeling	Approved	None posted
Feb 5, 1999	Supplement 16Labeling · Standard review	Approved	None posted
Oct 7, 1998	Supplement 17Manufacturing · Standard review	Approved	None posted
Feb 8, 1995	Supplement 15Manufacturing · Standard review	Approved	None posted
Dec 20, 1993	Supplement 14Labeling	Approved	None posted
Jan 19, 1990	Supplement 11Manufacturing · Standard review	Approved	None posted
Nov 19, 1986	Supplement 6Manufacturing · Standard review	Approved	None posted
Oct 16, 1985	Supplement 8Manufacturing · Standard review	Approved	None posted
Dec 6, 1984	Supplement 7Manufacturing · Standard review	Approved	None posted
Oct 26, 1983	Supplement 2Manufacturing · Standard review	Approved	None posted
Oct 26, 1983	Supplement 3Labeling	Approved	None posted
Oct 26, 1983	Supplement 5Labeling	Approved	None posted
Jun 8, 1951	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 7942
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