Protamine Sulfate

ANDA 89475, held by Hikma. Protamine Sulfate.

As of Nov 14, 2026, ANDA 89475 (Protamine Sulfate), held by Hikma, was first approved by FDA on Nov 5, 1986, with 13 approved supplements and 0 published complete response letters.

First approved: Nov 5, 1986
Supplements approved: 13
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

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

Products

2 strengths and forms


Protamine Sulfate250MG/25ML (10MG/ML) · solution;intravenous	Protamine Sulfate	Discontinued
Protamine Sulfate50MG/5ML (10MG/ML) · solution;intravenous	Protamine Sulfate	Discontinued

All 14 submissions, including labeling and manufacturing supplements


Mar 29, 2000	Supplement 15Manufacturing	Approved	None posted
Nov 5, 1998	Supplement 13Manufacturing	Approved	None posted
Nov 5, 1998	Supplement 14Manufacturing	Approved	None posted
Jan 30, 1996	Supplement 12Labeling	Approved	None posted
Aug 14, 1992	Supplement 9Labeling	Approved	None posted
Feb 6, 1992	Supplement 10Manufacturing	Approved	None posted
Dec 26, 1990	Supplement 11Labeling	Approved	None posted
May 17, 1989	Supplement 8Labeling	Approved	None posted
Oct 28, 1988	Supplement 7Labeling	Approved	None posted
Jun 7, 1988	Supplement 4Manufacturing	Approved	None posted
Jun 7, 1988	Supplement 5Manufacturing	Approved	None posted
Mar 15, 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 89475
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