Heparin Sodium

NDA 4570, held by Pharmacia And Upjohn. Heparin Sodium.

As of Nov 13, 2026, NDA 4570 (Heparin Sodium), held by Pharmacia And Upjohn, was first approved by FDA on Feb 5, 1942, with 34 approved supplements and 0 published complete response letters.

First approved: Feb 5, 1942
Supplements approved: 34
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 35 submissions below

Date	Submission	Status	Documents
Feb 5, 1942	Original application	Approved	None posted

Products

3 strengths and forms


Heparin Sodium1,000 UNITS/ML · injectable;injection	Heparin Sodium	Discontinued
Heparin Sodium5,000 UNITS/ML · injectable;injection	Heparin Sodium	Discontinued
Heparin Sodium10,000 UNITS/ML · injectable;injection	Heparin Sodium	Discontinued

All 35 submissions, including labeling and manufacturing supplements


Apr 3, 2000	Supplement 56Manufacturing	Approved	None posted
Sep 15, 1999	Supplement 55Labeling · Standard review	Approved	None posted
Mar 4, 1996	Supplement 54Labeling · Standard review	Approved	None posted
Jan 31, 1996	Supplement 53Manufacturing	Approved	None posted
Jul 9, 1991	Supplement 52Manufacturing	Approved	None posted
Jan 29, 1990	Supplement 49Manufacturing	Approved	None posted
Nov 16, 1988	Supplement 51Labeling	Approved	None posted
Aug 12, 1988	Supplement 50Labeling	Approved	None posted
Jan 29, 1988	Supplement 46Manufacturing	Approved	None posted
Jul 24, 1987	Supplement 48Labeling	Approved	None posted
Jan 21, 1987	Supplement 47Labeling	Approved	None posted
Oct 24, 1986	Supplement 43Labeling	Approved	None posted
Mar 25, 1983	Supplement 45Labeling	Approved	None posted
Jan 21, 1983	Supplement 44Labeling	Approved	None posted
Aug 19, 1981	Supplement 42Labeling	Approved	None posted
Jun 2, 1981	Supplement 41Labeling	Approved	None posted
Jun 2, 1981	Supplement 33Labeling	Approved	None posted
Feb 18, 1981	Supplement 35Labeling	Approved	None posted
Feb 4, 1981	Supplement 40Labeling	Approved	None posted
Jan 14, 1981	Supplement 39Labeling	Approved	None posted
Dec 3, 1980	Supplement 38Manufacturing	Approved	None posted
Oct 14, 1980	Supplement 36Manufacturing	Approved	None posted
Aug 20, 1980	Supplement 37Manufacturing	Approved	None posted
Feb 5, 1980	Supplement 34Manufacturing	Approved	None posted
Feb 5, 1980	Supplement 32Manufacturing	Approved	None posted
Feb 5, 1980	Supplement 31Manufacturing	Approved	None posted
Oct 4, 1978	Supplement 29Manufacturing	Approved	None posted
Feb 2, 1978	Supplement 26Manufacturing	Approved	None posted
Feb 11, 1977	Supplement 23Manufacturing	Approved	None posted
Jul 9, 1976	Supplement 20Manufacturing	Approved	None posted
Feb 24, 1976	Supplement 22Labeling	Approved	None posted
Feb 24, 1976	Supplement 21Labeling	Approved	None posted
Aug 14, 1975	Supplement 19Labeling	Approved	None posted
Aug 14, 1975	Supplement 18Manufacturing	Approved	None posted
Feb 5, 1942	Original application	Approved	None posted

Identifiers

Application: NDA 4570
Drugs@FDA: Overview at FDA
Company: Pharmacia & Upjohn

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