Treats venous thrombosis and pulmonary embolism. NDA 19339, held by Hospira. Heparin Sodium.
As of Nov 13, 2026, NDA 19339 (Heparin Sodium 12,500 Units In Dextrose 5% In Plastic Container, Heparin Sodium 25,000 Units In Dextrose 5% In Plastic Container, Heparin Sodium 10,000 Units In Dextrose 5% In Plastic Container), held by Hospira, was first approved by FDA on Mar 27, 1985, with 30 approved supplements and 0 published complete response letters.
Heparin Sodium in 5% Dextrose Injection is indicated for:
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 27, 1985 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Heparin Sodium 12,500 Units In Dextrose 5% In Plastic Container5,000 UNITS/100ML · injectable;injection | Heparin Sodium | Rx |
| Heparin Sodium 25,000 Units In Dextrose 5% In Plastic Container10,000 UNITS/100ML · injectable;injection | Heparin Sodium | Rx |
| Heparin Sodium 10,000 Units In Dextrose 5% In Plastic Container10,000 UNITS/100ML · injectable;injection | Heparin Sodium | Rx |
| Heparin Sodium 25,000 Units In Dextrose 5% In Plastic Container5,000 UNITS/100ML · injectable;injection | Heparin Sodium | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 7, 2024 | Supplement 68Labeling · Standard review | Approved | |
| Sep 4, 2019 | Supplement 52Labeling · Standard review | Approved | |
| Dec 20, 2018 | Supplement 62Labeling · Standard review | Approved | |
| Mar 13, 2014 | Supplement 54Labeling · Standard review | Approved | |
| Feb 8, 2013 | Supplement 50Manufacturing · Standard review | Approved | None posted |
| Dec 23, 2011 | Supplement 47Labeling · Standard review | Approved | |
| Jul 23, 2009 | Supplement 38Labeling · Standard review | Approved | |
| Oct 17, 2008 | Supplement 34Labeling · Standard review | Approved | |
| Nov 7, 2002 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Nov 19, 1999 | Supplement 24Labeling · Standard review | Approved | None posted |
| Oct 27, 1998 | Supplement 23Manufacturing · Standard review | Approved | None posted |
| Oct 27, 1998 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| May 27, 1998 | Supplement 19Labeling · Standard review | Approved | None posted |
| Mar 16, 1998 | Supplement 21Labeling · Standard review | Approved | None posted |
| Jun 9, 1997 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Aug 30, 1996 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Feb 7, 1996 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Aug 24, 1995 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Aug 22, 1995 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Nov 10, 1994 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Nov 10, 1994 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Nov 10, 1994 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Nov 10, 1994 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Feb 25, 1992 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Feb 18, 1992 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Feb 16, 1990 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Oct 29, 1986 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Sep 24, 1986 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Aug 3, 1986 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Apr 1, 1986 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Mar 27, 1985 | 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
