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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. 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. 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. Additional details are available on the methotrexate profile page.
Summary for 204824
| Tradename: | OTREXUP PFS |
| Applicant: | Antares Pharma Inc |
| Ingredient: | methotrexate |
| Patents: | 12 |
| Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 204824
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: | Mar 10, 2029 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| 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? | ||
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 | 204824-002 | Oct 11, 2013 | 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 | 204824-004 | Oct 11, 2013 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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