Filgrastim Injection
- Brand(s)
- Neupogen
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Amgen Inc (2015-07-30)
- Oldest Current Product
- 1994-06-08
- License(s)
- BLA
- RxNORM
- INJECTION\FILGRASTIM
- SPL Active
- INTRAVENOUS\INJECTION, SOLUTION\FILGRASTIM, LICENSE HOLDER UNSPECIFIED
- SPL Moiety
- INTRAVENOUS\INJECTION, SOLUTION\FILGRASTIM, LICENSE HOLDER UNSPECIFIED
product(s) by strength(s)
1 ml filgrastim 0.3 mg/ml injection
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 555130530 | Neupogen | BLA | Amgen Inc | 1997-05-19 | FILGRASTIM, LICENSE HOLDER UNSPECIFIED | INTRAVENOUS | INJECTION, SOLUTION | 103353 | 97cc73cc-b5b7-458a-a933-77b00523e193 |
relabeler product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 548682522 | Neupogen | BLA | Physicians Total Care, Inc. | 1994-06-08 | FILGRASTIM, LICENSE HOLDER UNSPECIFIED | INTRAVENOUS | INJECTION, SOLUTION | 555130530 | 103353 | 3bc802bd-76b4-4f45-8571-a436ec26228e |
1.6 ml filgrastim 0.3 mg/ml injection
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 555130546 | Neupogen | BLA | Amgen Inc | 1997-04-07 | FILGRASTIM, LICENSE HOLDER UNSPECIFIED | INTRAVENOUS | INJECTION, SOLUTION | 103353 | 97cc73cc-b5b7-458a-a933-77b00523e193 |
application(s)
| # | id | title | approved | tradenames | fda division |
|---|---|---|---|---|---|
| 1 | 103353 | filgrastim Application | 1991-02-20 | Neupogen | CDER |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) | in other drug docs |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 3bc802bd-76b4-4f45-8571-a436ec26228e (view SPL) | prescription | Human Prescription | Physicians Total Care, Inc. | relabel | 2009-12-02 | 1 | 548682522, 548683050, 548685020 | Filgrastim Prefilled Syringe | |
| 2 | 97cc73cc-b5b7-458a-a933-77b00523e193 (view SPL) | These highlights do not include all the information needed to use NEUPOGEN safely and effectively. See full prescribing information for NEUPOGEN. NEUPOGEN (filgrastim) injection, for subcutaneous or intravenous use Initial U.S. Approval: 1991 | prescription | Human Prescription | Amgen Inc | ANALYSIS, MANUFACTURE | 2015-07-30 | 144 | 555130530, 555130546, 555130209, 555130924 | Filgrastim Prefilled Syringe |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII