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Application 201657
- Type
- NDA
- Sponsor
- HOSPIRA INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | PARICALCITOL | PARICALCITOL | SOLUTION;INTRAVENOUS | 0.002MG/ML (0.002MG/ML) | No | No |
| 002 | PARICALCITOL | PARICALCITOL | SOLUTION;INTRAVENOUS | 0.005MG/ML (0.005MG/ML) | No | No |
| 003 | PARICALCITOL | PARICALCITOL | SOLUTION;INTRAVENOUS | 0.01MG/2ML (0.005MG/ML) | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0409-1007 | Paricalcitol | PARICALCITOL | Hospira, Inc. | NDA | Current |
| 0409-1007 | Paricalcitol | PARICALCITOL | Hospira, Inc. | NDA | Current |
| 0409-1007 | Paricalcitol | PARICALCITOL | Hospira, Inc. | NDA | Current |
| 0409-1007 | Paricalcitol | PARICALCITOL | Hospira, Inc. | NDA | Current |
| 0409-1007 | Paricalcitol | PARICALCITOL | Hospira, Inc. | NDA | Current |
| 0409-1008 | Paricalcitol | PARICALCITOL | Hospira, Inc. | NDA | Current |
| 0409-1008 | Paricalcitol | PARICALCITOL | Hospira, Inc. | NDA | Current |
| 0409-1008 | Paricalcitol | PARICALCITOL | Hospira, Inc. | NDA | Current |
| 0409-1008 | Paricalcitol | PARICALCITOL | Hospira, Inc. | NDA | Current |
| 0409-1008 | Paricalcitol | PARICALCITOL | Hospira, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 61361 | SUPPL | 2019-12-20 |
| 61315 | SUPPL | 2019-12-17 |
| 22855 | ORIG | 2015-01-16 |
| 19029 | ORIG | 2014-10-23 |
| 9920 | ORIG | 2014-10-23 |