Amgen Inc. (AMGN)
FDA Applications
Note: This list only includes applications that have been responded to by the FDA.
| Application | Product Name | Active Ingredient | Form | Strength | Status | ||
|---|---|---|---|---|---|---|---|
| BLA761344 - AMGEN INC | |||||||
| IMDELLTRA | TARLATAMAB-DLLE | INJECTABLE;INJECTION | 1MG | Prescription | |||
| IMDELLTRA | TARLATAMAB-DLLE | INJECTABLE;INJECTION | 10MG | Prescription | |||
| BLA761333 - AMGEN INC | |||||||
| BKEMV | ECULIZUMAB-AEEB | INJECTABLE;INJECTION | 300MG/30ML(10MG/ML) | Prescription | |||
| BLA761331 - AMGEN INC | |||||||
| WEZLANA | USTEKINUMAB-AUUB | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 130MG/26ML | Prescription | |||
| BLA761298 - AMGEN INC | |||||||
| PAVBLU | AFLIBERCEPT-AYYH | INJECTABLE;INJECTION | 2 mg (0.05 mL of 40 mg/mL) | Prescription | |||
| BLA761285 - AMGEN INC | |||||||
| WEZLANA | USTEKINUMAB-AUUB | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 45MG/0.5ML | Prescription | |||
| WEZLANA | USTEKINUMAB-AUUB | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 90MG/ML | Prescription | |||
| BLA761140 - AMGEN INC | |||||||
| RIABNI | RITUXIMAB-ARRX | INJECTABLE;INJECTION | 100MG/10ML(10MG/ML) | Prescription | |||
| BLA761086 - AMGEN INC | |||||||
| AVSOLA | INFLIXIMAB-AXXQ | INJECTABLE;INJECTION | 100MG/VIAL | Prescription | |||
| BLA761077 - AMGEN INC | |||||||
| AIMOVIG | ERENUMAB-AOOE | INJECTABLE;INJECTION | 70MG/ML | Prescription | |||
| BLA761073 - AMGEN INC | |||||||
| KANJINTI | TRASTUZUMAB-ANNS | VIAL; MULTIDOSE | 420MG | Prescription | |||
| KANJINTI | TRASTUZUMAB-ANNS | VIAL;SINGLE-DOSE | 150MG | Prescription | |||
| BLA761062 - AMGEN INC | |||||||
| EVENITY | ROMOSOZUMAB-AQQG | INJECTABLE;INJECTION | 105MG/1.17ML | Prescription | |||
| BLA761028 - AMGEN INC | |||||||
| MVASI | BEVACIZUMAB-AWWB | INJECTABLE; INJECTION | 100MG/4ML (25MG/ML) | Prescription | |||
| MVASI | BEVACIZUMAB-AWWB | INJECTABLE; INJECTION | 400MG/16ML (25MG/ML) | Prescription | |||
| BLA761024 - AMGEN INC | |||||||
| AMJEVITA | ADALIMUMAB-ATTO | INJECTABLE;INJECTION | 20MG/0.4ML | Prescription | |||
| AMJEVITA | ADALIMUMAB-ATTO | INJECTABLE;INJECTION | 40MG/0.8ML | Prescription | |||
| NDA214665 - AMGEN INC | |||||||
| LUMAKRAS | SOTORASIB | TABLET;ORAL | 320MG | Prescription | |||
| LUMAKRAS | SOTORASIB | TABLET;ORAL | 240MG | Prescription | |||
| LUMAKRAS | SOTORASIB | TABLET;ORAL | 120MG | Prescription | |||
| NDA209964 - AMGEN INC | |||||||
| CORLANOR | IVABRADINE | SOLUTION;ORAL | 5MG/5ML (1MG/ML) | Prescription | |||
| NDA206143 - AMGEN INC | |||||||
| CORLANOR | IVABRADINE HYDROCHLORIDE | TABLET;ORAL | EQ 7.5MG BASE | Prescription | |||
| CORLANOR | IVABRADINE HYDROCHLORIDE | TABLET;ORAL | EQ 5MG BASE | Prescription | |||
| NDA205437 - AMGEN INC | |||||||
| OTEZLA | APREMILAST | TABLET;ORAL | 10MG | Prescription | |||
| OTEZLA | APREMILAST | TABLET;ORAL | 20MG | Prescription | |||
| OTEZLA | APREMILAST | TABLET;ORAL | 30MG | Prescription | |||
| NDA202714 - ONYX PHARMS AMGEN | |||||||
| KYPROLIS | CARFILZOMIB | POWDER;INTRAVENOUS | 10MG/VIAL | Prescription | |||
| KYPROLIS | CARFILZOMIB | POWDER;INTRAVENOUS | 30MG/VIAL | Prescription | |||
| KYPROLIS | CARFILZOMIB | POWDER;INTRAVENOUS | 60MG/VIAL | Prescription | |||
| BLA125557 - AMGEN | |||||||
| BLINCYTO | BLINATUMOMAB | INJECTABLE;INJECTION | 35MCG | Prescription | |||
| BLA125522 - AMGEN INC | |||||||
| REPATHA | EVOLOCUMAB | INJECTABLE;INJECTION | 140MG/ML | Prescription | |||
| BLA125320 - AMGEN | |||||||
| PROLIA | DENOSUMAB | INJECTABLE; SUBCUTANEOUS | 60MG/ML | Prescription | |||
| XGEVA | DENOSUMAB | INJECTABLE; SUBCUTANEOUS | 70MG/ML | Prescription | |||
| BLA125268 - AMGEN | |||||||
| NPLATE | ROMIPLOSTIM | INJECTABLE; SUBCUTANEOUS | 250MCG/0.5ML; 500MCG/1ML. | Prescription | |||
| BLA125147 - AMGEN | |||||||
| VECTIBIX | PANITUMUMAB | INJECTABLE; IV (INFUSION) | 5ML/100MG | Prescription | |||
| VECTIBIX | PANITUMUMAB | INJECTABLE; IV (INFUSION) | 10ML/200MG | Prescription | |||
| VECTIBIX | PANITUMUMAB | INJECTABLE; IV (INFUSION) | 20ML/400MG | Prescription | |||
| BLA125031 - AMGEN | |||||||
| NEULASTA | PEGFILGRASTIM | SYRINGE | 6MG/0.6ML | Prescription | |||
| BLA103951 - AMGEN | |||||||
| ARANESP | DARBEPOETIN ALFA | VIAL; INTRAVENOUS | 25UG/ML | Prescription | |||
| ARANESP | DARBEPOETIN ALFA | VIAL; INTRAVENOUS | 40UG/ML | Prescription | |||
| ARANESP | DARBEPOETIN ALFA | VIAL; INTRAVENOUS | 60UG/ML | Prescription | |||
| ARANESP | DARBEPOETIN ALFA | VIAL; INTRAVENOUS | 100UG/ML | Prescription | |||
| ARANESP | DARBEPOETIN ALFA | VIAL; INTRAVENOUS | 200UG/ML | Prescription | |||
| ARANESP | DARBEPOETIN ALFA | VIAL; SUBCUTANEOUS | 25UG/ML | Prescription | |||
| ARANESP | DARBEPOETIN ALFA | VIAL; SUBCUTANEOUS | 40UG/ML | Prescription | |||
| ARANESP | DARBEPOETIN ALFA | VIAL; SUBCUTANEOUS | 60UG/ML | Prescription | |||
| ARANESP | DARBEPOETIN ALFA | VIAL; SUBCUTANEOUS | 100UG/ML | Prescription | |||
| ARANESP | DARBEPOETIN ALFA | VIAL; SUBCUTANEOUS | 200UG/ML | Prescription | |||
| BLA103353 - AMGEN | |||||||
| NEUPOGEN | FILGRASTIM | SYRINGE | 480MCG/0.8ML | Prescription | |||
| NEUPOGEN | FILGRASTIM | SYRINGE | 300MGC/0.5ML | Prescription | |||
| NEUPOGEN | FILGRASTIM | VIAL | 480MCG/1.6ML | Prescription | |||
| NEUPOGEN | FILGRASTIM | VIAL | 300MCG/1ML | Prescription | |||
| BLA103234 - AMGEN | |||||||
| EPOGEN/PROCRIT | EPOETIN ALFA | VIAL; SINGLE-USE | 10,000U/ML | Prescription | |||
| EPOGEN/PROCRIT | EPOETIN ALFA | VIAL; MULTIDOSE | 20,000U/2ML | Prescription | |||
| EPOGEN/PROCRIT | EPOETIN ALFA | VIAL; MULTIDOSE | 20,000/ML | Prescription | |||
| EPOGEN/PROCRIT | EPOETIN ALFA | VIAL; SINGLE-USE | 2,000U/ML | Prescription | |||
| EPOGEN/PROCRIT | EPOETIN ALFA | VIAL; SINGLE-USE | 3,000U/ML | Prescription | |||
| EPOGEN/PROCRIT | EPOETIN ALFA | VIAL; SINGLE-USE | 40,000U/ML | Prescription | |||
| EPOGEN/PROCRIT | EPOETIN ALFA | VIAL; SINGLE-USE | 4,000U/ML | Prescription | |||
| NDA021688 - AMGEN | |||||||
| SENSIPAR | CINACALCET HYDROCHLORIDE | TABLET;ORAL | EQ 90MG BASE | Prescription | |||
| SENSIPAR | CINACALCET HYDROCHLORIDE | TABLET;ORAL | EQ 30MG BASE | Prescription | |||
| SENSIPAR | CINACALCET HYDROCHLORIDE | TABLET;ORAL | EQ 60MG BASE | Prescription | |||