Heparin Sodium

NDA 17979, held by Abraxis Pharm. Heparin Sodium.

As of Nov 13, 2026, NDA 17979 (Heparin Sodium), held by Abraxis Pharm, was first approved by FDA on Dec 21, 1978, with 22 approved supplements and 0 published complete response letters.

First approved: Dec 21, 1978
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
Dec 19, 1983	Supplement 11Efficacy (new indication or use)	Approved	None posted
Dec 21, 1978	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

3 strengths and forms

Product	Active ingredient	Marketing
Heparin Sodium1,000 UNITS/ML · injectable;injection	Heparin Sodium	Discontinued
Heparin Sodium10,000 UNITS/ML · injectable;injection	Heparin Sodium	Discontinued
Heparin Sodium5,000 UNITS/ML · injectable;injection	Heparin Sodium	Discontinued

All 23 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jan 6, 2003	Supplement 29Manufacturing · Standard review	Approved	None posted
Sep 28, 2001	Supplement 28Manufacturing · Standard review	Approved	None posted
Dec 13, 1999	Supplement 26Manufacturing · Standard review	Approved	None posted
Dec 22, 1997	Supplement 25Manufacturing · Standard review	Approved	None posted
Jun 2, 1995	Supplement 24Manufacturing · Standard review	Approved	None posted
Aug 26, 1993	Supplement 21Labeling	Approved	None posted
Feb 9, 1989	Supplement 18Labeling	Approved	None posted
Oct 19, 1988	Supplement 16Labeling	Approved	None posted
Sep 17, 1986	Supplement 15Manufacturing · Standard review	Approved	None posted
Jul 29, 1985	Supplement 14Labeling	Approved	None posted
Jan 8, 1985	Supplement 13Manufacturing · Standard review	Approved	None posted
Sep 19, 1984	Supplement 12Manufacturing · Standard review	Approved	None posted
Dec 19, 1983	Supplement 11Efficacy (new indication or use)	Approved	None posted
Jan 12, 1983	Supplement 10Manufacturing · Standard review	Approved	None posted
Sep 23, 1980	Supplement 9Manufacturing · Standard review	Approved	None posted
Oct 19, 1979	Supplement 5Manufacturing · Standard review	Approved	None posted
Oct 19, 1979	Supplement 7Manufacturing · Standard review	Approved	None posted
Oct 10, 1979	Supplement 6Manufacturing · Standard review	Approved	None posted
Oct 3, 1979	Supplement 3Manufacturing · Standard review	Approved	None posted
Sep 18, 1979	Supplement 4Manufacturing · Standard review	Approved	None posted
May 29, 1979	Supplement 2Manufacturing · Standard review	Approved	None posted
Mar 29, 1979	Supplement 1Manufacturing · Standard review	Approved	None posted
Dec 21, 1978	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 17979
Drugs@FDA: Overview at FDA
Company: Abraxis Pharmaceuticals

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