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Application 019115
- Type
- NDA
- Sponsor
- HOSPIRA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | FENTANYL CITRATE | FENTANYL CITRATE | INJECTABLE;INJECTION | EQ 0.05MG BASE/ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0409-9093 | FENTANYL CITRATE | fentanyl citrate | Hospira, Inc. | NDA | Current |
| 0409-9093 | FENTANYL CITRATE | fentanyl citrate | Hospira, Inc. | NDA | Current |
| 0409-9093 | FENTANYL CITRATE | fentanyl citrate | Hospira, Inc. | NDA | Current |
| 0409-9093 | FENTANYL CITRATE | fentanyl citrate | Hospira, Inc. | NDA | Current |
| 0409-9093 | Fentanyl Citrate | FENTANYL CITRATE | Hospira, Inc. | NDA | Current |
| 0409-9093 | FENTANYL CITRATE | fentanyl citrate | Hospira, Inc. | NDA | Current |
| 0409-9093 | Fentanyl Citrate | FENTANYL CITRATE | Hospira, Inc. | NDA | Current |
| 0409-9093 | Fentanyl Citrate | FENTANYL CITRATE | Hospira, Inc. | NDA | Current |
| 0409-9093 | Fentanyl Citrate | FENTANYL CITRATE | Hospira, Inc. | NDA | Current |
| 0409-9093 | Fentanyl Citrate | FENTANYL CITRATE | Hospira, Inc. | NDA | Current |
| 0409-9093 | FENTANYL CITRATE | fentanyl citrate | Hospira, Inc. | NDA | Current |
| 0409-9093 | FENTANYL CITRATE | fentanyl citrate | Hospira, Inc. | NDA | Current |
| 0409-9093 | Fentanyl Citrate | FENTANYL CITRATE | Hospira, Inc. | NDA | Current |
| 0409-9093 | Fentanyl Citrate | FENTANYL CITRATE | Hospira, Inc. | NDA | Current |
| 0409-9093 | FENTANYL CITRATE | fentanyl citrate | Hospira, Inc. | NDA | Current |
| 0409-9094 | FENTANYL CITRATE | fentanyl citrate | Hospira, Inc. | NDA | Current |
| 0409-9094 | FENTANYL CITRATE | fentanyl citrate | Hospira, Inc. | NDA | Current |
| 0409-9094 | Fentanyl Citrate | FENTANYL CITRATE | Hospira, Inc. | NDA | Current |
| 0409-9094 | FENTANYL CITRATE | fentanyl citrate | Hospira, Inc. | NDA | Current |
| 0409-9094 | Fentanyl Citrate | FENTANYL CITRATE | Hospira, Inc. | NDA | Current |
| 0409-9094 | Fentanyl Citrate | FENTANYL CITRATE | Hospira, Inc. | NDA | Current |
| 0409-9094 | FENTANYL CITRATE | fentanyl citrate | Hospira, Inc. | NDA | Current |
| 0409-9094 | Fentanyl Citrate | FENTANYL CITRATE | Hospira, Inc. | NDA | Current |
| 0409-9094 | Fentanyl Citrate | FENTANYL CITRATE | Hospira, Inc. | NDA | Current |
| 0409-9094 | FENTANYL CITRATE | fentanyl citrate | Hospira, Inc. | NDA | Current |
| 0409-9094 | Fentanyl Citrate | FENTANYL CITRATE | Hospira, Inc. | NDA | Current |
| 0409-9094 | Fentanyl Citrate | FENTANYL CITRATE | Hospira, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 84709 | SUPPL | 2026-01-07 |
| 84561 | SUPPL | 2025-12-29 |
| 76990 | SUPPL | 2023-12-19 |
| 76888 | SUPPL | 2023-12-18 |
| 60416 | SUPPL | 2019-10-09 |
| 60270 | SUPPL | 2019-10-07 |
| 46399 | SUPPL | 2016-12-21 |
| 46398 | SUPPL | 2016-12-21 |
| 46229 | SUPPL | 2016-12-20 |
| 46228 | SUPPL | 2016-12-20 |