NDA 18911, held by Hospira. Heparin Sodium.
As of Nov 13, 2026, NDA 18911 (Heparin Sodium 10,000 Units In Sodium Chloride 0.45%, Heparin Sodium 5,000 Units In Sodium Chloride 0.45%, Heparin Sodium 10,000 Units In Sodium Chloride 0.9%), held by Hospira, was first approved by FDA on Jan 30, 1985, with 9 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 30, 1985 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Heparin Sodium 10,000 Units In Sodium Chloride 0.45%10,000 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 0.9%10,000 UNITS/100ML · injectable;injection | Heparin Sodium | Discontinued |
| Heparin Sodium 25,000 Units In Sodium Chloride 0.9%5,000 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 10,000 Units In Dextrose 5%10,000 UNITS/100ML · injectable;injection | Heparin Sodium | Discontinued |
| Heparin Sodium 12,500 Units In Dextrose 5%5,000 UNITS/100ML · injectable;injection | Heparin Sodium | Discontinued |
| Heparin Sodium 25,000 Units In Dextrose 5%10,000 UNITS/100ML · injectable;injection | Heparin Sodium | Discontinued |
| Heparin Sodium 25,000 Units In Dextrose 5%5,000 UNITS/100ML · injectable;injection | Heparin Sodium | Discontinued |
| Aug 24, 1999 | Supplement 10Labeling · Standard review | Approved | None posted |
| May 27, 1998 | Supplement 9Labeling · Standard review | Approved | None posted |
| Aug 29, 1996 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Aug 24, 1995 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Feb 25, 1992 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Jul 24, 1991 | Supplement 5Labeling · Standard review | Approved | None posted |
| Sep 14, 1987 | Supplement 3Labeling · Standard review | Approved | None posted |
| Sep 24, 1986 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Jul 29, 1985 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jan 30, 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
