Application 018916
- Type
- NDA
- Sponsor
- HOSPIRA
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9% | HEPARIN SODIUM | INJECTABLE;INJECTION | 1,000 UNITS/100ML | No | No |
| 002 | HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.9% | HEPARIN SODIUM | INJECTABLE;INJECTION | 10,000 UNITS/100ML | No | No |
| 003 | HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.9% | HEPARIN SODIUM | INJECTABLE;INJECTION | 5,000 UNITS/100ML | No | No |
| 004 | HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.45% | HEPARIN SODIUM | INJECTABLE;INJECTION | 100 UNITS/ML | No | No |
| 005 | HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.45% | HEPARIN SODIUM | INJECTABLE;INJECTION | 10,000 UNITS/100ML | No | No |
| 006 | HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | HEPARIN SODIUM | INJECTABLE;INJECTION | 5,000 UNITS/100ML | No | No |
| 007 | HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | HEPARIN SODIUM | INJECTABLE;INJECTION | 5,000 UNITS/100ML | No | No |
| 008 | HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | HEPARIN SODIUM | INJECTABLE;INJECTION | 10,000 UNITS/100ML | No | No |
| 009 | HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | HEPARIN SODIUM | INJECTABLE;INJECTION | 5,000 UNITS/100ML | No | No |
| 010 | HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | HEPARIN SODIUM | INJECTABLE;INJECTION | 200 UNITS/100ML | Yes | Yes |
| 011 | HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | HEPARIN SODIUM | INJECTABLE;INJECTION | 200 UNITS/100ML | Yes | Yes |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0409-3150 | Heparin Sodium | HEPARIN SODIUM | Hospira, Inc. | NDA | Current |
| 0409-7620 | Heparin Sodium | HEPARIN SODIUM | Hospira, Inc. | NDA | Current |
| 0409-7620 | Heparin Sodium | HEPARIN SODIUM | Hospira, Inc. | NDA | Current |
| 0409-7620 | Heparin Sodium | HEPARIN SODIUM | Hospira, Inc. | NDA | Current |
| 0409-7620 | Heparin Sodium | HEPARIN SODIUM | Hospira, Inc. | NDA | Current |
| 0409-7620 | Heparin Sodium | HEPARIN SODIUM | Hospira, Inc. | NDA | Current |
| 0409-7650 | Heparin Sodium | HEPARIN SODIUM | Hospira, Inc. | NDA | Current |
| 0409-7650 | Heparin Sodium | HEPARIN SODIUM | Hospira, Inc. | NDA | Current |
| 0409-7650 | Heparin Sodium | HEPARIN SODIUM | Hospira, Inc. | NDA | Current |
| 0409-7650 | Heparin Sodium | HEPARIN SODIUM | Hospira, Inc. | NDA | Current |
| 0409-7650 | Heparin Sodium | HEPARIN SODIUM | Hospira, Inc. | NDA | Current |
| 0409-7651 | Heparin Sodium | HEPARIN SODIUM | Hospira, Inc. | NDA | Current |
| 0409-7651 | Heparin Sodium | HEPARIN SODIUM | Hospira, Inc. | NDA | Current |
| 0409-7651 | Heparin Sodium | HEPARIN SODIUM | Hospira, Inc. | NDA | Current |
| 0409-7651 | Heparin Sodium | HEPARIN SODIUM | Hospira, Inc. | NDA | Current |
| 0409-7651 | Heparin Sodium | HEPARIN SODIUM | Hospira, Inc. | NDA | Current |
| 51662-1411 | HEPARIN SODIUM | HEPARIN SODIUM | HF Acquisition Co LLC, DBA HealthFirst | NDA | Current |
| 51662-1411 | HEPARIN SODIUM | HEPARIN SODIUM | HF Acquisition Co LLC, DBA HealthFirst | NDA | Current |
Documents
| Document | Title | Submission type | Submission no. | Date |
|---|---|---|---|---|
| 84321 | 0 | SUPPL | 83 | 2025-11-26 |
| 84241 | 0 | SUPPL | 83 | 2025-11-21 |
| 80563 | 0 | SUPPL | 80 | 2024-12-13 |
| 80552 | 0 | SUPPL | 80 | 2024-12-11 |
| 80009 | 0 | SUPPL | 79 | 2024-10-28 |
| 79995 | 0 | SUPPL | 79 | 2024-10-25 |
| 64167 | 0 | SUPPL | 71 | 2020-08-03 |
| 64151 | 0 | SUPPL | 71 | 2020-07-31 |
| 59917 | 0 | SUPPL | 63 | 2019-09-05 |
| 59910 | 0 | SUPPL | 63 | 2019-09-05 |
| 33644 | 0 | SUPPL | 69 | 2016-04-12 |
| 33643 | 0 | SUPPL | 66 | 2016-04-12 |
| 16090 | 0 | SUPPL | 69 | 2016-04-07 |
| 1126 | 0 | SUPPL | 66 | 2016-04-07 |
| 33642 | 0 | SUPPL | 60 | 2013-02-14 |
| 1125 | 0 | SUPPL | 60 | 2013-02-13 |
| 16089 | 0 | SUPPL | 57 | 2011-12-29 |
| 11359 | 0 | SUPPL | 57 | 2011-12-23 |