Treats venous thrombosis and pulmonary embolism. NDA 18916, held by Hospira. Heparin Sodium.
As of Nov 13, 2026, NDA 18916 (Heparin Sodium 5,000 Units In Sodium Chloride 0.9%, Heparin Sodium 10,000 Units In Sodium Chloride 0.9%, Heparin Sodium 12,500 Units In Sodium Chloride 0.9%), held by Hospira, was first approved by FDA on Jan 31, 1984, with 41 approved supplements and 0 published complete response letters.
HEPARIN SODIUM IN SODIUM CHLORIDE INJECTION is indicated for:
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 23, 1989 | Supplement 8Efficacy (new indication or use) | Approved | None posted |
| Jan 31, 1984 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Heparin Sodium 5,000 Units In Sodium Chloride 0.9%1,000 UNITS/100ML · injectable;injection | Heparin Sodium | Discontinued |
| Heparin Sodium 10,000 Units In Sodium Chloride 0.9%10,000 UNITS/100ML · injectable;injection | Heparin Sodium | Discontinued |
| Heparin Sodium 12,500 Units In Sodium Chloride 0.9%5,000 UNITS/100ML · injectable;injection | Heparin Sodium | Discontinued |
| Heparin Sodium 5,000 Units In Sodium Chloride 0.45%100 UNITS/ML · injectable;injection | Heparin Sodium | Discontinued |
| Heparin Sodium 10,000 Units In Sodium Chloride 0.45%10,000 UNITS/100ML · injectable;injection | Heparin Sodium | Discontinued |
| Heparin Sodium 12,500 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 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 |
| Heparin Sodium 25,000 Units In Sodium Chloride 0.9% In Plastic Container5,000 UNITS/100ML · injectable;injection | Heparin Sodium | Discontinued |
| 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 |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 19, 2025 | Supplement 83Labeling · Standard review | Approved | |
| Dec 10, 2024 | Supplement 80Labeling · Standard review | Approved | |
| Oct 24, 2024 | Supplement 79Labeling · Standard review | Approved | |
| Jul 30, 2020 | Supplement 71Labeling · Standard review | Approved | |
| Sep 4, 2019 | Supplement 63Labeling · Standard review | Approved | |
| Jul 18, 2016 | Supplement 70Manufacturing · Standard review | Approved | None posted |
| Apr 5, 2016 | Supplement 69Labeling · Standard review | Approved | |
| Apr 5, 2016 | Supplement 66Labeling · Standard review | Approved | |
| Apr 14, 2015 | Supplement 68Manufacturing · Standard review | Approved | None posted |
| Mar 3, 2015 | Supplement 67Manufacturing · Standard review | Approved | None posted |
| Jan 15, 2014 | Supplement 64Manufacturing · Standard review | Approved | None posted |
| Jul 15, 2013 | Supplement 62Manufacturing · Standard review | Approved | None posted |
| Feb 12, 2013 | Supplement 60Labeling · Standard review | Approved | |
| Feb 8, 2013 | Supplement 61Manufacturing · Standard review | Approved | None posted |
| Nov 30, 2012 | Supplement 59Manufacturing · Standard review | Approved | None posted |
| Dec 23, 2011 | Supplement 57Labeling · Standard review | Approved | |
| Nov 19, 1999 | Supplement 33Labeling · Standard review | Approved | None posted |
| Oct 27, 1998 | Supplement 32Manufacturing · Standard review | Approved | None posted |
| Aug 25, 1998 | Supplement 28Labeling · Standard review | Approved | None posted |
| Aug 29, 1997 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| Jun 25, 1997 | Supplement 30Manufacturing · Standard review | Approved | None posted |
| Jun 9, 1997 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Apr 3, 1997 | Supplement 27Manufacturing · Standard review | Approved | None posted |
| Sep 5, 1996 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Aug 30, 1996 | Supplement 23Manufacturing · Standard review | Approved | None posted |
| Aug 29, 1996 | Supplement 26Manufacturing · Standard review | Approved | None posted |
| Feb 7, 1996 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Feb 25, 1992 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Feb 18, 1992 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Oct 2, 1991 | Supplement 21Labeling | Approved | None posted |
| Oct 29, 1990 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Feb 16, 1990 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Jun 23, 1989 | Supplement 8Efficacy (new indication or use) | Approved | None posted |
| Oct 24, 1988 | Supplement 12Labeling | Approved | None posted |
| Aug 21, 1987 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Oct 29, 1986 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Aug 8, 1986 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Oct 29, 1985 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Oct 29, 1985 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Apr 16, 1985 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Sep 24, 1984 | Supplement 1Labeling | Approved | None posted |
| Jan 31, 1984 | 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
