Protamine Sulfate

ANDA 89474, held by Hikma. Protamine Sulfate.

As of Nov 15, 2026, ANDA 89474 (Protamine Sulfate), held by Hikma, was first approved by FDA on Nov 5, 1986, with 11 approved supplements and 0 published complete response letters.

First approved: Nov 5, 1986
Supplements approved: 11
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

Date	Submission	Status	Documents
Nov 5, 1986	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Protamine Sulfate50MG/5ML (10MG/ML) · solution;intravenous	Protamine Sulfate	Discontinued

All 12 submissions, including labeling and manufacturing supplements


Jun 29, 2000	Supplement 13Manufacturing	Approved	None posted
Mar 29, 1999	Supplement 12Manufacturing	Approved	None posted
Nov 5, 1998	Supplement 11Manufacturing	Approved	None posted
Jan 30, 1996	Supplement 10Labeling	Approved	None posted
Dec 28, 1994	Supplement 9Manufacturing	Approved	None posted
Aug 14, 1992	Supplement 6Labeling	Approved	None posted
Dec 26, 1990	Supplement 8Labeling	Approved	None posted
May 17, 1989	Supplement 5Labeling	Approved	None posted
Oct 28, 1988	Supplement 4Labeling	Approved	None posted
Mar 8, 1988	Supplement 2Manufacturing	Approved	None posted
Nov 6, 1987	Supplement 3Manufacturing	Approved	None posted
Nov 5, 1986	Original application	Approved	None posted

Identifiers

Application: ANDA 89474
Drugs@FDA: Overview at FDA
Company: Hikma

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