Protamine Sulfate

NDA 6460, held by Lilly. Protamine Sulfate.

As of Nov 13, 2026, NDA 6460 (Protamine Sulfate), held by Lilly, was first approved by FDA on Aug 13, 1969, with 22 approved supplements and 0 published complete response letters.

First approved: Aug 13, 1969
Review: Standard
Supplements approved: 22
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 23 submissions below

Date	Submission	Status	Documents
Aug 13, 1969	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

2 strengths and forms


Protamine Sulfate50MG/5ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · solution;intravenous	Protamine Sulfate	DiscontinuedReference drug
Protamine Sulfate250MG/25ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · solution;intravenous	Protamine Sulfate	DiscontinuedReference drug

All 23 submissions, including labeling and manufacturing supplements


Apr 22, 1998	Supplement 31Manufacturing · Standard review	Approved	None posted
Apr 8, 1997	Supplement 30Manufacturing · Standard review	Approved	None posted
Dec 3, 1996	Supplement 28Manufacturing · Standard review	Approved	None posted
Apr 19, 1996	Supplement 29Manufacturing · Standard review	Approved	None posted
Dec 6, 1994	Supplement 27Labeling · Standard review	Approved	None posted
Aug 18, 1993	Supplement 26Labeling · Standard review	Approved	None posted
Jan 8, 1991	Supplement 24Labeling · Standard review	Approved	None posted
Mar 5, 1990	Supplement 23Labeling · Standard review	Approved	None posted
Jun 13, 1989	Supplement 22Labeling · Standard review	Approved	None posted
Feb 18, 1988	Supplement 20Manufacturing · Standard review	Approved	None posted
Jan 7, 1988	Supplement 21Labeling · Standard review	Approved	None posted
May 27, 1986	Supplement 18Labeling · Standard review	Approved	None posted
Oct 29, 1985	Supplement 16Manufacturing · Standard review	Approved	None posted
Oct 24, 1985	Supplement 17Labeling · Standard review	Approved	None posted
Jun 17, 1985	Supplement 13Labeling · Standard review	Approved	None posted
May 25, 1983	Supplement 15Manufacturing · Standard review	Approved	None posted
Apr 21, 1982	Supplement 14Labeling · Standard review	Approved	None posted
Jan 21, 1982	Supplement 12Labeling · Standard review	Approved	None posted
Jun 16, 1981	Supplement 11Manufacturing · Standard review	Approved	None posted
Oct 27, 1979	Supplement 9Labeling · Standard review	Approved	None posted
Sep 7, 1979	Supplement 10Manufacturing · Standard review	Approved	None posted
Jul 21, 1976	Supplement 8Labeling · Standard review	Approved	None posted
Aug 13, 1969	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 6460
Drugs@FDA: Overview at FDA
Company: Lilly

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