Heparin Sodium 1,000 Units In Sodium Chloride 0.9% In Plastic Container, Heparin Sodium 2,000 Units In Sodium Chloride 0.9% In Plastic Container, Heparin Sodium 5,000 Units In Sodium Chloride 0.9% In Plastic Container

NDA 19042, held by B Braun. Heparin Sodium.

As of Nov 13, 2026, NDA 19042 (Heparin Sodium 1,000 Units In Sodium Chloride 0.9% In Plastic Container, Heparin Sodium 2,000 Units In Sodium Chloride 0.9% In Plastic Container, Heparin Sodium 5,000 Units In Sodium Chloride 0.9% In Plastic Container), held by B Braun, was first approved by FDA on Mar 29, 1985, with 5 approved supplements and 0 published complete response letters.

First approved: Mar 29, 1985
Review: Standard
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Mar 29, 1985	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

3 strengths and forms

Product	Active ingredient	Marketing
Heparin Sodium 1,000 Units In Sodium Chloride 0.9% In Plastic Container200 UNITS/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Heparin Sodium	Discontinued
Heparin Sodium 2,000 Units In Sodium Chloride 0.9% In Plastic Container200 UNITS/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Heparin Sodium	Discontinued
Heparin Sodium 5,000 Units In Sodium Chloride 0.9% In Plastic Container1,000 UNITS/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Heparin Sodium	Discontinued

All 6 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Apr 20, 1992	Supplement 6Manufacturing · Standard review	Approved	None posted
Mar 30, 1990	Supplement 5Manufacturing · Standard review	Approved	None posted
Jun 21, 1989	Supplement 4Labeling · Standard review	Approved	None posted
Apr 17, 1987	Supplement 2Manufacturing · Standard review	Approved	None posted
Sep 10, 1985	Supplement 1Manufacturing · Standard review	Approved	None posted
Mar 29, 1985	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 19042
Drugs@FDA: Overview at FDA
Company: B. Braun Medical

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