| 54436-012-01 |
54436-012 |
HUMAN PRESCRIPTION DRUG |
Otrexup |
methotrexate |
INJECTION, SOLUTION |
SUBCUTANEOUS |
20160324 |
20270430 |
NDA |
NDA204824 |
Antares Pharma, Inc. |
METHOTREXATE |
12.5 mg/.4mL |
1 SYRINGE in 1 CARTON (54436-012-01) / .4 mL in 1 SYRINGE |
| 54436-012-03 |
54436-012 |
HUMAN PRESCRIPTION DRUG |
Otrexup |
methotrexate |
INJECTION, SOLUTION |
SUBCUTANEOUS |
20160324 |
20270430 |
NDA |
NDA204824 |
Antares Pharma, Inc. |
METHOTREXATE |
12.5 mg/.4mL |
1 SYRINGE in 1 CARTON (54436-012-03) / .4 mL in 1 SYRINGE |
| 54436-012-04 |
54436-012 |
HUMAN PRESCRIPTION DRUG |
Otrexup |
methotrexate |
INJECTION, SOLUTION |
SUBCUTANEOUS |
20160324 |
20270430 |
NDA |
NDA204824 |
Antares Pharma, Inc. |
METHOTREXATE |
12.5 mg/.4mL |
4 SYRINGE in 1 CARTON (54436-012-04) / .4 mL in 1 SYRINGE (54436-012-02) |
| 54436-022-01 |
54436-022 |
HUMAN PRESCRIPTION DRUG |
Otrexup |
methotrexate |
INJECTION, SOLUTION |
SUBCUTANEOUS |
20160324 |
20270430 |
NDA |
NDA204824 |
Antares Pharma, Inc. |
METHOTREXATE |
22.5 mg/.4mL |
1 SYRINGE in 1 CARTON (54436-022-01) / .4 mL in 1 SYRINGE |
| 54436-022-03 |
54436-022 |
HUMAN PRESCRIPTION DRUG |
Otrexup |
methotrexate |
INJECTION, SOLUTION |
SUBCUTANEOUS |
20160324 |
20270430 |
NDA |
NDA204824 |
Antares Pharma, Inc. |
METHOTREXATE |
22.5 mg/.4mL |
1 SYRINGE in 1 CARTON (54436-022-03) / .4 mL in 1 SYRINGE |
| 54436-022-04 |
54436-022 |
HUMAN PRESCRIPTION DRUG |
Otrexup |
methotrexate |
INJECTION, SOLUTION |
SUBCUTANEOUS |
20160324 |
20270430 |
NDA |
NDA204824 |
Antares Pharma, Inc. |
METHOTREXATE |
22.5 mg/.4mL |
4 SYRINGE in 1 CARTON (54436-022-04) / .4 mL in 1 SYRINGE (54436-022-02) |
| 82497-015-04 |
82497-015 |
HUMAN PRESCRIPTION DRUG |
Otrexup |
methotrexate |
INJECTION, SOLUTION |
SUBCUTANEOUS |
20240925 |
N/A |
NDA |
NDA204824 |
Otter Pharmaceuticals, LLC |
METHOTREXATE |
15 mg/.4mL |
4 SYRINGE in 1 CARTON (82497-015-04) / .4 mL in 1 SYRINGE (82497-015-02) |
| 82497-025-04 |
82497-025 |
HUMAN PRESCRIPTION DRUG |
Otrexup |
methotrexate |
INJECTION, SOLUTION |
SUBCUTANEOUS |
20240925 |
N/A |
NDA |
NDA204824 |
Otter Pharmaceuticals, LLC |
METHOTREXATE |
25 mg/.4mL |
4 SYRINGE in 1 CARTON (82497-025-04) / .4 mL in 1 SYRINGE (82497-025-02) |
| 54436-017-01 |
54436-017 |
HUMAN PRESCRIPTION DRUG |
Otrexup |
methotrexate |
INJECTION, SOLUTION |
SUBCUTANEOUS |
20160324 |
20270430 |
NDA |
NDA204824 |
Antares Pharma, Inc. |
METHOTREXATE |
17.5 mg/.4mL |
1 SYRINGE in 1 CARTON (54436-017-01) / .4 mL in 1 SYRINGE |
| 54436-017-03 |
54436-017 |
HUMAN PRESCRIPTION DRUG |
Otrexup |
methotrexate |
INJECTION, SOLUTION |
SUBCUTANEOUS |
20160324 |
20270430 |
NDA |
NDA204824 |
Antares Pharma, Inc. |
METHOTREXATE |
17.5 mg/.4mL |
1 SYRINGE in 1 CARTON (54436-017-03) / .4 mL in 1 SYRINGE |
| 54436-017-04 |
54436-017 |
HUMAN PRESCRIPTION DRUG |
Otrexup |
methotrexate |
INJECTION, SOLUTION |
SUBCUTANEOUS |
20160324 |
20270430 |
NDA |
NDA204824 |
Antares Pharma, Inc. |
METHOTREXATE |
17.5 mg/.4mL |
4 SYRINGE in 1 CARTON (54436-017-04) / .4 mL in 1 SYRINGE (54436-017-02) |
| 82497-010-04 |
82497-010 |
HUMAN PRESCRIPTION DRUG |
Otrexup |
methotrexate |
INJECTION, SOLUTION |
SUBCUTANEOUS |
20240925 |
N/A |
NDA |
NDA204824 |
Otter Pharmaceuticals, LLC |
METHOTREXATE |
10 mg/.4mL |
4 SYRINGE in 1 CARTON (82497-010-04) / .4 mL in 1 SYRINGE (82497-010-02) |
| 82497-020-04 |
82497-020 |
HUMAN PRESCRIPTION DRUG |
Otrexup |
methotrexate |
INJECTION, SOLUTION |
SUBCUTANEOUS |
20240925 |
N/A |
NDA |
NDA204824 |
Otter Pharmaceuticals, LLC |
METHOTREXATE |
20 mg/.4mL |
4 SYRINGE in 1 CARTON (82497-020-04) / .4 mL in 1 SYRINGE (82497-020-02) |
| 54436-010-01 |
54436-010 |
HUMAN PRESCRIPTION DRUG |
Otrexup |
methotrexate |
INJECTION, SOLUTION |
SUBCUTANEOUS |
20131011 |
20270430 |
NDA |
NDA204824 |
Antares Pharma, Inc. |
METHOTREXATE |
10 mg/.4mL |
1 SYRINGE in 1 CARTON (54436-010-01) / .4 mL in 1 SYRINGE |
| 54436-010-03 |
54436-010 |
HUMAN PRESCRIPTION DRUG |
Otrexup |
methotrexate |
INJECTION, SOLUTION |
SUBCUTANEOUS |
20131011 |
20270430 |
NDA |
NDA204824 |
Antares Pharma, Inc. |
METHOTREXATE |
10 mg/.4mL |
1 SYRINGE in 1 CARTON (54436-010-03) / .4 mL in 1 SYRINGE |
| 54436-010-04 |
54436-010 |
HUMAN PRESCRIPTION DRUG |
Otrexup |
methotrexate |
INJECTION, SOLUTION |
SUBCUTANEOUS |
20131011 |
20270430 |
NDA |
NDA204824 |
Antares Pharma, Inc. |
METHOTREXATE |
10 mg/.4mL |
4 SYRINGE in 1 CARTON (54436-010-04) / .4 mL in 1 SYRINGE (54436-010-02) |
| 54436-020-01 |
54436-020 |
HUMAN PRESCRIPTION DRUG |
Otrexup |
methotrexate |
INJECTION, SOLUTION |
SUBCUTANEOUS |
20131011 |
20270430 |
NDA |
NDA204824 |
Antares Pharma, Inc. |
METHOTREXATE |
20 mg/.4mL |
1 SYRINGE in 1 CARTON (54436-020-01) / .4 mL in 1 SYRINGE |
| 54436-020-03 |
54436-020 |
HUMAN PRESCRIPTION DRUG |
Otrexup |
methotrexate |
INJECTION, SOLUTION |
SUBCUTANEOUS |
20131011 |
20270430 |
NDA |
NDA204824 |
Antares Pharma, Inc. |
METHOTREXATE |
20 mg/.4mL |
1 SYRINGE in 1 CARTON (54436-020-03) / .4 mL in 1 SYRINGE |
| 54436-020-04 |
54436-020 |
HUMAN PRESCRIPTION DRUG |
Otrexup |
methotrexate |
INJECTION, SOLUTION |
SUBCUTANEOUS |
20131011 |
20270430 |
NDA |
NDA204824 |
Antares Pharma, Inc. |
METHOTREXATE |
20 mg/.4mL |
4 SYRINGE in 1 CARTON (54436-020-04) / .4 mL in 1 SYRINGE (54436-020-02) |
| 82497-012-04 |
82497-012 |
HUMAN PRESCRIPTION DRUG |
Otrexup |
methotrexate |
INJECTION, SOLUTION |
SUBCUTANEOUS |
20240925 |
N/A |
NDA |
NDA204824 |
Otter Pharmaceuticals, LLC |
METHOTREXATE |
12.5 mg/.4mL |
4 SYRINGE in 1 CARTON (82497-012-04) / .4 mL in 1 SYRINGE (82497-012-02) |