Skip to contentApplication 761075
- Type
- BLA
- Sponsor
- MYLAN GMBH
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | FULPHILA | PEGFILGRASTIM-JMDB | INJECTABLE;INJECTION | 6MG/0.6ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 67457-833 | Fulphila | pegfilgrastim | Mylan Institutional LLC | BLA | Current |
| 67457-833 | Fulphila | pegfilgrastim | Mylan Institutional LLC | BLA | Current |
| 67457-833 | Fulphila | pegfilgrastim | Mylan Institutional LLC | BLA | Current |
| 67457-833 | Fulphila | pegfilgrastim | Mylan Institutional LLC | BLA | Current |
| 67457-833 | Fulphila | pegfilgrastim | Mylan Institutional LLC | BLA | Current |
| 67457-833 | Fulphila | pegfilgrastim | Mylan Institutional LLC | BLA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 75842 | SUPPL | 2023-10-19 |
| 75778 | SUPPL | 2023-10-16 |
| 66848 | SUPPL | 2021-03-24 |
| 66811 | SUPPL | 2021-03-19 |
| 58932 | SUPPL | 2019-06-04 |
| 58894 | SUPPL | 2019-05-30 |
| 58071 | SUPPL | 2019-03-25 |
| 58061 | SUPPL | 2019-03-22 |
| 56169 | ORIG | 2018-10-30 |
| 54435 | ORIG | 2018-06-04 |
| 54434 | ORIG | 2018-06-04 |