Application 017651
- Type
- NDA
- Sponsor
- FRESENIUS KABI USA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 003 | HEPARIN SODIUM | HEPARIN SODIUM | INJECTABLE;INJECTION | 10,000 UNITS/ML | No | No |
| 005 | HEPARIN SODIUM | HEPARIN SODIUM | INJECTABLE;INJECTION | 1,000 UNITS/ML | No | No |
| 006 | HEPARIN SODIUM | HEPARIN SODIUM | INJECTABLE;INJECTION | 5,000 UNITS/ML | Yes | Yes |
| 008 | HEPARIN SODIUM | HEPARIN SODIUM | INJECTABLE;INJECTION | 20,000 UNITS/ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 63323-047 | Heparin Sodium | HEPARIN SODIUM | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-047 | Heparin Sodium | HEPARIN SODIUM | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-047 | Heparin Sodium | HEPARIN SODIUM | Fresenius Kabi USA, LLC | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 80008 | SUPPL | 2024-10-28 |
| 79994 | SUPPL | 2024-10-25 |
| 67736 | SUPPL | 2021-06-08 |
| 63805 | SUPPL | 2020-07-06 |
| 63796 | SUPPL | 2020-07-06 |
| 677 | SUPPL | 2014-04-07 |
| 676 | SUPPL | 2011-12-29 |
| 33328 | SUPPL | 2011-12-23 |
| 675 | SUPPL | 2011-07-05 |
| 11051 | SUPPL | 2010-06-24 |
| 13878 | SUPPL | 2010-06-14 |
| 33327 | SUPPL | 2009-04-03 |
| 674 | SUPPL | 2009-04-03 |
| 13877 | SUPPL | 2008-01-09 |
| 20081 | ORIG | 2007-07-20 |