| 210745 | NDA | AMGEN INC | | 002 | OTEZLA | TABLET;ORAL | 20MG | APREMILAST | 2025-08-29 | Prescription | No |
| 003 | OTEZLA | TABLET;ORAL | 30MG | APREMILAST | 2025-08-29 | Prescription | No |
| 001 | OTEZLA XR | TABLET, EXTENDED RELEASE;ORAL | 75MG | APREMILAST | 2025-08-29 | Prescription | Yes |
| 004 | OTEZLA XR | TABLET;EXTENDED RELEASE | 75MG | APREMILAST | 2025-08-29 | Prescription | No |
| 761298 | BLA | AMGEN INC | | 001 | PAVBLU | INJECTABLE;INJECTION | 2 mg (0.05 mL of 40 mg/mL) | AFLIBERCEPT-AYYH | 2024-08-23 | Prescription | No |
| 761333 | BLA | AMGEN INC | | 001 | BKEMV | INJECTABLE;INJECTION | 300MG/30ML(10MG/ML) | ECULIZUMAB-AEEB | 2024-05-28 | Prescription | No |
| 761344 | BLA | AMGEN INC | | 001 | IMDELLTRA | INJECTABLE;INJECTION | 1MG | TARLATAMAB-DLLE | 2024-05-16 | Prescription | No |
| 002 | IMDELLTRA | INJECTABLE;INJECTION | 10MG | TARLATAMAB-DLLE | 2024-05-16 | Prescription | No |
| 761285 | BLA | AMGEN INC | | 001 | WEZLANA | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 45MG/0.5ML | USTEKINUMAB-AUUB | 2023-10-31 | Prescription | No |
| 002 | WEZLANA | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 90MG/ML | USTEKINUMAB-AUUB | 2023-10-31 | Prescription | No |
| 761331 | BLA | AMGEN INC | | 001 | WEZLANA | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 130MG/26ML | USTEKINUMAB-AUUB | 2023-10-31 | Prescription | No |
| 214665 | NDA | AMGEN INC | | 001 | LUMAKRAS | TABLET;ORAL | 120MG | SOTORASIB | 2021-05-28 | Prescription | No |
| 002 | LUMAKRAS | TABLET;ORAL | 320MG | SOTORASIB | 2021-05-28 | Prescription | Yes |
| 003 | LUMAKRAS | TABLET;ORAL | 240MG | SOTORASIB | 2021-05-28 | Prescription | No |
| 761140 | BLA | AMGEN INC | | 001 | RIABNI | INJECTABLE;INJECTION | 100MG/10ML(10MG/ML) | RITUXIMAB-ARRX | 2020-12-17 | Prescription | No |
| 761086 | BLA | AMGEN INC | | 001 | AVSOLA | INJECTABLE;INJECTION | 100MG/VIAL | INFLIXIMAB-AXXQ | 2019-12-06 | Prescription | No |
| 761073 | BLA | AMGEN INC | | 001 | KANJINTI | VIAL; MULTIDOSE | 420MG | TRASTUZUMAB-ANNS | 2019-06-13 | Prescription | No |
| 002 | KANJINTI | VIAL;SINGLE-DOSE | 150MG | TRASTUZUMAB-ANNS | 2019-06-13 | Prescription | No |
| 209964 | NDA | AMGEN INC | | 001 | CORLANOR | SOLUTION;ORAL | 5MG/5ML (1MG/ML) | IVABRADINE | 2019-04-22 | Prescription | Yes |
| 761062 | BLA | AMGEN INC | | 001 | EVENITY | INJECTABLE;INJECTION | 105MG/1.17ML | ROMOSOZUMAB-AQQG | 2019-04-09 | Prescription | No |
| 761077 | BLA | AMGEN INC | | 001 | AIMOVIG | INJECTABLE;INJECTION | 70MG/ML | ERENUMAB-AOOE | 2018-05-17 | Prescription | No |
| 761028 | BLA | AMGEN INC | | 001 | MVASI | INJECTABLE; INJECTION | 100MG/4ML (25MG/ML) | BEVACIZUMAB-AWWB | 2017-09-14 | Prescription | No |
| 002 | MVASI | INJECTABLE; INJECTION | 400MG/16ML (25MG/ML) | BEVACIZUMAB-AWWB | 2017-09-14 | Prescription | No |
| 761024 | BLA | AMGEN INC | | 001 | AMJEVITA | INJECTABLE;INJECTION | 20MG/0.4ML | ADALIMUMAB-ATTO | 2016-09-23 | Prescription | No |
| 002 | AMJEVITA | INJECTABLE;INJECTION | 40MG/0.8ML | ADALIMUMAB-ATTO | 2016-09-23 | Prescription | No |
| 125522 | BLA | AMGEN INC | | 001 | REPATHA | INJECTABLE;INJECTION | 140MG/ML | EVOLOCUMAB | 2015-08-27 | Prescription | No |
| 206143 | NDA | AMGEN INC | | 001 | CORLANOR | TABLET;ORAL | EQ 5MG BASE | IVABRADINE HYDROCHLORIDE | 2015-04-15 | Prescription | No |
| 002 | CORLANOR | TABLET;ORAL | EQ 7.5MG BASE | IVABRADINE HYDROCHLORIDE | 2015-04-15 | Prescription | Yes |
| 125557 | BLA | AMGEN | | 001 | BLINCYTO | INJECTABLE;INJECTION | 35MCG | BLINATUMOMAB | 2014-12-03 | Prescription | No |
| 205437 | NDA | AMGEN INC | | 001 | OTEZLA | TABLET;ORAL | 10MG | APREMILAST | 2014-03-21 | Prescription | No |
| 002 | OTEZLA | TABLET;ORAL | 20MG | APREMILAST | 2014-03-21 | Prescription | No |
| 003 | OTEZLA | TABLET;ORAL | 30MG | APREMILAST | 2014-03-21 | Prescription | Yes |
| 202714 | NDA | ONYX PHARMS AMGEN | | 001 | KYPROLIS | POWDER;INTRAVENOUS | 60MG/VIAL | CARFILZOMIB | 2012-07-20 | Prescription | Yes |
| 002 | KYPROLIS | POWDER;INTRAVENOUS | 30MG/VIAL | CARFILZOMIB | 2012-07-20 | Prescription | Yes |
| 003 | KYPROLIS | POWDER;INTRAVENOUS | 10MG/VIAL | CARFILZOMIB | 2012-07-20 | Prescription | Yes |
| 125320 | BLA | AMGEN | | 001 | PROLIA | INJECTABLE; SUBCUTANEOUS | 60MG/ML | DENOSUMAB | 2010-06-01 | Prescription | No |
| 002 | XGEVA | INJECTABLE; SUBCUTANEOUS | 70MG/ML | DENOSUMAB | 2010-06-01 | Prescription | No |
| 125268 | BLA | AMGEN | | 001 | NPLATE | INJECTABLE; SUBCUTANEOUS | 250MCG/0.5ML; 500MCG/1ML. | ROMIPLOSTIM | 2008-08-22 | Prescription | No |
| 125147 | BLA | AMGEN | | 001 | VECTIBIX | INJECTABLE; IV (INFUSION) | 5ML/100MG | PANITUMUMAB | 2006-09-27 | Prescription | No |
| 002 | VECTIBIX | INJECTABLE; IV (INFUSION) | 10ML/200MG | PANITUMUMAB | 2006-09-27 | Prescription | No |
| 003 | VECTIBIX | INJECTABLE; IV (INFUSION) | 20ML/400MG | PANITUMUMAB | 2006-09-27 | Prescription | No |
| 021688 | NDA | AMGEN | | 001 | SENSIPAR | TABLET;ORAL | EQ 30MG BASE | CINACALCET HYDROCHLORIDE | 2004-03-08 | Discontinued | No |
| 002 | SENSIPAR | TABLET;ORAL | EQ 60MG BASE | CINACALCET HYDROCHLORIDE | 2004-03-08 | Discontinued | No |
| 003 | SENSIPAR | TABLET;ORAL | EQ 90MG BASE | CINACALCET HYDROCHLORIDE | 2004-03-08 | Discontinued | No |
| 125031 | BLA | AMGEN | | 001 | NEULASTA | SYRINGE | 6MG/0.6ML | PEGFILGRASTIM | 2002-01-31 | Prescription | No |
| 103951 | BLA | AMGEN | | 001 | ARANESP | VIAL; INTRAVENOUS | 25UG/ML | DARBEPOETIN ALFA | 2001-09-17 | Prescription | No |
| 002 | ARANESP | VIAL; INTRAVENOUS | 40UG/ML | DARBEPOETIN ALFA | 2001-09-17 | Prescription | No |
| 003 | ARANESP | VIAL; INTRAVENOUS | 60UG/ML | DARBEPOETIN ALFA | 2001-09-17 | Prescription | No |
| 004 | ARANESP | VIAL; INTRAVENOUS | 100UG/ML | DARBEPOETIN ALFA | 2001-09-17 | Prescription | No |
| 005 | ARANESP | VIAL; INTRAVENOUS | 200UG/ML | DARBEPOETIN ALFA | 2001-09-17 | Prescription | No |
| 006 | ARANESP | VIAL; SUBCUTANEOUS | 25UG/ML | DARBEPOETIN ALFA | 2001-09-17 | Prescription | No |
| 007 | ARANESP | VIAL; SUBCUTANEOUS | 40UG/ML | DARBEPOETIN ALFA | 2001-09-17 | Prescription | No |
| 008 | ARANESP | VIAL; SUBCUTANEOUS | 60UG/ML | DARBEPOETIN ALFA | 2001-09-17 | Prescription | No |
| 009 | ARANESP | VIAL; SUBCUTANEOUS | 100UG/ML | DARBEPOETIN ALFA | 2001-09-17 | Prescription | No |
| 010 | ARANESP | VIAL; SUBCUTANEOUS | 200UG/ML | DARBEPOETIN ALFA | 2001-09-17 | Prescription | No |
| 103353 | BLA | AMGEN | | 001 | NEUPOGEN | VIAL | 300MCG/1ML | FILGRASTIM | 1991-02-20 | Prescription | No |
| 002 | NEUPOGEN | VIAL | 480MCG/1.6ML | FILGRASTIM | 1991-02-20 | Prescription | No |
| 003 | NEUPOGEN | SYRINGE | 300MGC/0.5ML | FILGRASTIM | 1991-02-20 | Prescription | No |
| 004 | NEUPOGEN | SYRINGE | 480MCG/0.8ML | FILGRASTIM | 1991-02-20 | Prescription | No |
| 103234 | BLA | AMGEN | | 001 | EPOGEN/PROCRIT | VIAL; SINGLE-USE | 10,000U/ML | EPOETIN ALFA | 1989-06-01 | Prescription | No |
| 002 | EPOGEN/PROCRIT | VIAL; MULTIDOSE | 20,000U/2ML | EPOETIN ALFA | 1989-06-01 | Prescription | No |
| 003 | EPOGEN/PROCRIT | VIAL; MULTIDOSE | 20,000/ML | EPOETIN ALFA | 1989-06-01 | Prescription | No |
| 004 | EPOGEN/PROCRIT | VIAL; SINGLE-USE | 2,000U/ML | EPOETIN ALFA | 1989-06-01 | Prescription | No |
| 005 | EPOGEN/PROCRIT | VIAL; SINGLE-USE | 3,000U/ML | EPOETIN ALFA | 1989-06-01 | Prescription | No |
| 006 | EPOGEN/PROCRIT | VIAL; SINGLE-USE | 40,000U/ML | EPOETIN ALFA | 1989-06-01 | Prescription | No |
| 007 | EPOGEN/PROCRIT | VIAL; SINGLE-USE | 4,000U/ML | EPOETIN ALFA | 1989-06-01 | Prescription | No |