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Details for New Drug Application (NDA): 204824
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NDA 204824 describes OTREXUP PFS, which is a drug marketed by Antares Pharma Inc and is included in one NDA. It is available from one supplier. Additional details are available on the OTREXUP PFS profile page.
The generic ingredient in OTREXUP PFS is methotrexate. There are twenty drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the methotrexate profile page.
The generic ingredient in OTREXUP PFS is methotrexate. There are twenty drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the methotrexate profile page.
Summary for 204824
| Tradename: | OTREXUP PFS |
| Applicant: | Antares Pharma Inc |
| Ingredient: | methotrexate |
| Patents: | 9 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 204824
| Mechanism of Action | Folic Acid Metabolism Inhibitors |
Medical Subject Heading (MeSH) Categories for 204824
Suppliers and Packaging for NDA: 204824
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OTREXUP | methotrexate | SOLUTION;SUBCUTANEOUS | 204824 | NDA | Antares Pharma, Inc. | 54436-010 | 54436-010-01 | 1 SYRINGE in 1 CARTON (54436-010-01) > .4 mL in 1 SYRINGE |
| OTREXUP PFS | methotrexate | SOLUTION;SUBCUTANEOUS | 204824 | NDA | Antares Pharma, Inc. | 54436-010 | 54436-010-01 | 1 SYRINGE in 1 CARTON (54436-010-01) > .4 mL in 1 SYRINGE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;SUBCUTANEOUS | Strength | 10MG/0.4ML (10MG/0.4ML) | ||||
| Approval Date: | Oct 11, 2013 | TE: | RLD: | Yes | |||||
| Patent: | Start Trial | Patent Expiration: | Apr 12, 2020 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | Start Trial | Patent Expiration: | Oct 4, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | Start Trial | Patent Expiration: | Mar 19, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | SUBCUTANEOUS INJECTION OF METHOTREXATE | ||||||||
Expired US Patents for NDA 204824
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Antares Pharma Inc | OTREXUP | methotrexate | SOLUTION;SUBCUTANEOUS | 204824-006 | Mar 24, 2016 | Start Trial | Start Trial |
| Antares Pharma Inc | OTREXUP | methotrexate | SOLUTION;SUBCUTANEOUS | 204824-002 | Oct 11, 2013 | Start Trial | Start Trial |
| Antares Pharma Inc | OTREXUP | methotrexate | SOLUTION;SUBCUTANEOUS | 204824-008 | Mar 24, 2016 | Start Trial | Start Trial |
| Antares Pharma Inc | OTREXUP | methotrexate | SOLUTION;SUBCUTANEOUS | 204824-003 | Oct 11, 2013 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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