Application 019339
- Type
- NDA
- Sponsor
- HOSPIRA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | HEPARIN SODIUM | INJECTABLE;INJECTION | 5,000 UNITS/100ML | No | No |
| 002 | HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | HEPARIN SODIUM | INJECTABLE;INJECTION | 10,000 UNITS/100ML | No | No |
| 003 | HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | HEPARIN SODIUM | INJECTABLE;INJECTION | 10,000 UNITS/100ML | No | No |
| 004 | HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | HEPARIN SODIUM | INJECTABLE;INJECTION | 5,000 UNITS/100ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0409-4520 | Heparin Sodium and Dextrose | HEPARIN SODIUM | Hospira, Inc. | NDA | Current |
| 0409-7793 | Heparin Sodium and Dextrose | HEPARIN SODIUM | Hospira, Inc. | NDA | Current |
| 0409-7793 | Heparin Sodium and Dextrose | HEPARIN SODIUM | Hospira, Inc. | NDA | Current |
| 0409-7793 | Heparin Sodium and Dextrose | HEPARIN SODIUM | Hospira, Inc. | NDA | Current |
| 0409-7793 | Heparin Sodium and Dextrose | HEPARIN SODIUM | Hospira, Inc. | NDA | Current |
| 0409-7793 | Heparin Sodium and Dextrose | HEPARIN SODIUM | Hospira, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 77424 | SUPPL | 2024-02-08 |
| 77419 | SUPPL | 2024-02-07 |
| 59918 | SUPPL | 2019-09-05 |
| 59911 | SUPPL | 2019-09-05 |
| 57002 | SUPPL | 2018-12-21 |
| 56964 | SUPPL | 2018-12-21 |
| 11478 | SUPPL | 2014-03-19 |
| 17361 | SUPPL | 2014-03-18 |
| 17360 | SUPPL | 2011-12-29 |
| 33726 | SUPPL | 2011-12-23 |
| 17359 | SUPPL | 2009-07-31 |
| 1288 | SUPPL | 2008-10-21 |