Skip to content
Application 020122
- Type
- NDA
- Sponsor
- HOSPIRA INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | NIPENT | PENTOSTATIN | INJECTABLE;INJECTION | 10MG/VIAL | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0409-0801 | Nipent | PENTOSTATIN | Hospira, Inc. | NDA | Current |
| 0409-0801 | Nipent | PENTOSTATIN | Hospira, Inc. | NDA | Current |
| 0409-0801 | Nipent | PENTOSTATIN | Hospira, Inc. | NDA | Current |
| 0409-0801 | Nipent | PENTOSTATIN | Hospira, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 84057 | SUPPL | 2025-11-04 |
| 84047 | SUPPL | 2025-11-04 |
| 60701 | SUPPL | 2019-10-29 |
| 60699 | SUPPL | 2019-10-29 |