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Application 208614
- Type
- NDA
- Sponsor
- HOSPIRA INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | DOXERCALCIFEROL | DOXERCALCIFEROL | INJECTABLE;INJECTION | 4MCG/2ML (2MCG/ML) | Yes | No |
| 002 | DOXERCALCIFEROL | DOXERCALCIFEROL | INJECTABLE;INJECTION | 10MCG/5ML (2MCG/ML) | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0409-1330 | DOXERCALCIFEROL | DOXERCALCIFEROL | Hospira, Inc. | NDA | Current |
| 0409-1330 | DOXERCALCIFEROL | DOXERCALCIFEROL | Hospira, Inc. | NDA | Current |
| 0409-1330 | DOXERCALCIFEROL | DOXERCALCIFEROL | Hospira, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 59890 | SUPPL | 2019-08-30 |
| 59876 | SUPPL | 2019-08-29 |
| 56104 | ORIG | 2018-10-26 |
| 54995 | ORIG | 2018-07-26 |
| 54970 | ORIG | 2018-07-25 |