Panheprin, Heparin Lock Flush, Heparin Sodium Preservative Free

NDA 5264, held by Hospira. Heparin Sodium.

As of Nov 14, 2026, NDA 5264 (Panheprin, Heparin Lock Flush, Heparin Sodium Preservative Free), held by Hospira, was first approved by FDA on May 4, 1943, with 21 approved supplements and 0 published complete response letters.

First approved: May 4, 1943
Review: Standard
Supplements approved: 21
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 22 submissions below


May 21, 1985	Supplement 50Efficacy (new indication or use)	Approved	None posted
May 15, 1981	Supplement 42Efficacy (new indication or use)	Approved	None posted
May 4, 1943	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

8 strengths and forms


Panheprin1,000 UNITS/ML · injectable;injection	Heparin Sodium	Discontinued
Panheprin5,000 UNITS/ML · injectable;injection	Heparin Sodium	Discontinued
Panheprin10,000 UNITS/ML · injectable;injection	Heparin Sodium	Discontinued
Panheprin20,000 UNITS/ML · injectable;injection	Heparin Sodium	Discontinued
Panheprin40,000 UNITS/ML · injectable;injection	Heparin Sodium	Discontinued
Heparin Lock Flush100 UNITS/ML · injectable;injection	Heparin Sodium	Discontinued
Heparin Sodium Preservative Free2,000 UNITS/ML · injectable;injection	Heparin Sodium	Discontinued
Heparin Sodium Preservative Free2,500 UNITS/ML · injectable;injection	Heparin Sodium	Discontinued

All 22 submissions, including labeling and manufacturing supplements


Dec 23, 2011	Supplement 93Labeling · Standard review	Approved	None posted
Mar 21, 2000	Supplement 73Labeling · Standard review	Approved	None posted
Sep 16, 1998	Supplement 70Labeling · Standard review	Approved	None posted
Oct 29, 1992	Supplement 65Labeling · Standard review	Approved	None posted
Mar 24, 1992	Supplement 63Labeling	Approved	None posted
Jul 24, 1991	Supplement 60Labeling	Approved	None posted
Nov 22, 1988	Supplement 58Labeling	Approved	None posted
May 21, 1985	Supplement 50Efficacy (new indication or use)	Approved	None posted
Oct 4, 1984	Supplement 48Labeling	Approved	None posted
Oct 26, 1981	Supplement 45Labeling	Approved	None posted
May 15, 1981	Supplement 42Efficacy (new indication or use)	Approved	None posted
Apr 22, 1981	Supplement 43Labeling	Approved	None posted
Feb 18, 1981	Supplement 40Labeling	Approved	None posted
Sep 29, 1980	Supplement 37Labeling	Approved	None posted
Jul 2, 1980	Supplement 39Labeling	Approved	None posted
May 15, 1978	Supplement 31Labeling	Approved	None posted
Jan 4, 1978	Supplement 29Labeling	Approved	None posted
Nov 4, 1977	Supplement 27Labeling	Approved	None posted
Sep 22, 1976	Supplement 20Labeling	Approved	None posted
Sep 22, 1976	Supplement 19Labeling	Approved	None posted
Sep 22, 1976	Supplement 18Labeling	Approved	None posted
May 4, 1943	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 5264
Drugs@FDA: Overview at FDA
Company: Hospira

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