Protamine Sulfate

Treats heparin overdosage. ANDA 89454, held by Fresenius Kabi USA. Protamine Sulfate.

As of Nov 14, 2026, ANDA 89454 (Protamine Sulfate), held by Fresenius Kabi USA, was first approved by FDA on Apr 7, 1987, with 8 approved supplements and 0 published complete response letters.

First approved: Apr 7, 1987
Supplements approved: 8
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE: Protamine Sulfate Injection, USP is indicated in the treatment of heparin overdosage.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Apr 7, 1987	Original application	Approved	None posted

Products

2 strengths and forms


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

All 9 submissions, including labeling and manufacturing supplements


Jun 11, 2007	Supplement 15Labeling	Approved	None posted
Mar 29, 2007	Supplement 14Labeling	Approved	None posted
Dec 5, 2002	Supplement 12Manufacturing	Approved	None posted
Mar 1, 2002	Supplement 11Manufacturing	Approved	None posted
Oct 27, 1992	Supplement 7Labeling	Approved	None posted
Feb 22, 1991	Supplement 5Manufacturing	Approved	None posted
May 23, 1990	Supplement 8Labeling	Approved	None posted
Aug 25, 1987	Supplement 2Manufacturing	Approved	None posted
Apr 7, 1987	Original application	Approved	None posted

Identifiers

Application: ANDA 89454
Drugs@FDA: Overview at FDA
Company: Fresenius Kabi USA

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