Epoetin Alfa Injection
- Brand(s)
- Epogen, Procrit
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Amgen Inc (2014-06-27)
- Oldest Current Product
- 1989-06-01
- License(s)
- BLA
- RxNORM
- INJECTION\EPOETIN ALFA
- SPL Active
- INTRAVENOUS\INJECTION, SOLUTION\ERYTHROPOIETIN
INTRAVENOUS\SOLUTION\ERYTHROPOIETIN - SPL Moiety
- INTRAVENOUS\INJECTION, SOLUTION\ERYTHROPOIETIN
INTRAVENOUS\SOLUTION\ERYTHROPOIETIN
product(s) by strength(s)
1 ml epoetin alfa 10000 unt/ml injection
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 596760310 | Procrit | BLA | Janssen Products, Lp | 1989-06-01 | ERYTHROPOIETIN | INTRAVENOUS | INJECTION, SOLUTION | 103234 | 0c721ba4-ae19-417f-aae1-221ed1a0866a |
relabeler product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 548682523 | Procrit | BLA | Physicians Total Care, Inc. | 1994-08-11 | ERYTHROPOIETIN | INTRAVENOUS | INJECTION, SOLUTION | 596760310 | 103234 | 9bbe9a5b-ad1d-41a4-9699-ff6dc776bce1 |
1 ml epoetin alfa 2000 unt/ml injection
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 596760302 | Procrit | BLA | Janssen Products, Lp | 1989-06-01 | ERYTHROPOIETIN | INTRAVENOUS | INJECTION, SOLUTION | 103234 | 0c721ba4-ae19-417f-aae1-221ed1a0866a |
1 ml epoetin alfa 3000 unt/ml injection
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 555130267 | Epogen | BLA | Amgen Inc | 1990-04-30 | ERYTHROPOIETIN | INTRAVENOUS | SOLUTION | 103234 | 1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5 |
1 ml epoetin alfa 4000 unt/ml injection
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 596760304 | Procrit | BLA | Janssen Products, Lp | 1989-06-01 | ERYTHROPOIETIN | INTRAVENOUS | INJECTION, SOLUTION | 103234 | 0c721ba4-ae19-417f-aae1-221ed1a0866a |
1 ml epoetin alfa 40000 unt/ml injection
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 596760340 | Procrit | BLA | Janssen Products, Lp | 1989-06-01 | ERYTHROPOIETIN | INTRAVENOUS | INJECTION, SOLUTION | 103234 | 0c721ba4-ae19-417f-aae1-221ed1a0866a |
relabeler product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 548685802 | Procrit | BLA | Physicians Total Care, Inc. | 2007-08-13 | ERYTHROPOIETIN | INTRAVENOUS | INJECTION, SOLUTION | 596760340 | 103234 | 9bbe9a5b-ad1d-41a4-9699-ff6dc776bce1 |
application(s)
| # | id | title | approved | tradenames | fda division |
|---|---|---|---|---|---|
| 1 | 103234 | epoetin alfa Application | 1989-06-01 | Epogen/Procrit | CDER |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) | in other drug docs |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 0c721ba4-ae19-417f-aae1-221ed1a0866a (view SPL) | These highlights do not include all the information needed to use PROCRIT safely and effectively. See full prescribing information for PROCRIT. PROCRIT (epoetin alfa) injection, for intravenous or subcutaneous use Initial U.S. Approval: 1989 | prescription | Human Prescription | Janssen Products, Lp | ANALYSIS, MANUFACTURE | 2013-12-31 | 21 | 596760302, 596760304, 596760310, 596760340, 596760303, 596760312, 596760320 | Epoetin Alfa Injectable Solution |
| 2 | 1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5 (view SPL) | These highlights do not include all the information needed to use Epogen safely and effectively. See full prescribing information for Epogen. Epogen (epoetin alfa)injection, for intravenous or subcutaneous useInitial U.S. Approval: 1989 | prescription | Human Prescription | Amgen Inc | ANALYSIS, MANUFACTURE | 2014-06-27 | 121 | 555130267, 555130126, 555130144, 555130148, 555130283, 555130478, 555130823 | Epoetin Alfa Injectable Solution |
| 3 | 9bbe9a5b-ad1d-41a4-9699-ff6dc776bce1 (view SPL) | These highlights do not include all the information needed to use PROCRIT safely and effectively. See full prescribing information for PROCRIT. PROCRIT (epoetin alfa) injection, for intravenous or subcutaneous use Initial U.S. Approval: 1989 | prescription | Human Prescription | Physicians Total Care, Inc. | relabel | 2013-01-17 | 2 | 548682523, 548685802, 548685673 | Epoetin Alfa Injectable Solution |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII