Treats venous thrombosis and pulmonary embolism. NDA 19953, held by B Braun. Heparin Sodium.
As of Nov 13, 2026, NDA 19953 (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 25,000 Units In Sodium Chloride 0.45% In Plastic Container), held by B Braun, was first approved by FDA on Jul 20, 1992, with 20 approved supplements and 0 published complete response letters.
Heparin Sodium in 0.45% Sodium Chloride Injection is indicated for: Prophylaxis and treatment of venous thrombosis and pulmonary embolism; Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation; Treatment of acute and chronic consumption coagulopathies (disseminated intravascular coagulation); Prevention of clotting in arterial and cardiac surgery; Prophylaxis and treatment of peripheral arterial embolism; Anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 20, 1992 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Heparin Sodium 1,000 Units In Sodium Chloride 0.9% In Plastic Container200 UNITS/100ML · injectable;injection | Heparin Sodium | RxReference drug |
| Heparin Sodium 2,000 Units In Sodium Chloride 0.9% In Plastic Container200 UNITS/100ML · injectable;injection | Heparin Sodium | RxReference drug |
| Heparin Sodium 25,000 Units In Sodium Chloride 0.45% In Plastic Container5,000 UNITS/100ML · injectable;injection | Heparin Sodium | RxReference drug |
| Heparin Sodium 25,000 Units In Sodium Chloride 0.45% In Plastic Container10,000 UNITS/100ML · injectable;injection | Heparin Sodium | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 26, 2026 | Supplement 50Labeling · Standard review | Approved | |
| Mar 25, 2025 | Supplement 48Labeling · Standard review | Approved | |
| Dec 15, 2023 | Supplement 44Labeling · Standard review | Approved | |
| May 12, 2016 | Supplement 32Labeling · Standard review | Approved | |
| Aug 22, 2014 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Aug 30, 2013 | Supplement 30Labeling · Standard review | Approved | |
| Jan 10, 2013 | Supplement 29Labeling · Standard review | Approved | |
| Dec 27, 2011 | Supplement 25Labeling · Standard review | Approved | |
| Feb 26, 2009 | Supplement 21Labeling · Standard review | Approved | |
| Apr 13, 2004 | Supplement 12Labeling · Standard review | Approved | |
| Jul 12, 2002 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Feb 15, 2002 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Nov 22, 2000 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Mar 1, 2000 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Jun 5, 1998 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Jul 30, 1996 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Mar 9, 1995 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Mar 29, 1993 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Dec 22, 1992 | Supplement 3Labeling · Standard review | Approved | None posted |
| Dec 2, 1992 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Jul 20, 1992 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
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
