Details for New Drug Application (NDA): 205776
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NDA 205776 describes RASUVO, which is a drug marketed by Medexus and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the RASUVO profile page.
The generic ingredient in RASUVO is methotrexate. There are twenty drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the methotrexate profile page.
The generic ingredient in RASUVO is methotrexate. There are twenty drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the methotrexate profile page.
Summary for 205776
| Tradename: | RASUVO |
| Applicant: | Medexus |
| Ingredient: | methotrexate |
| Patents: | 1 |
| Formulation / Manufacturing: | see details |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 205776
Generic Entry Date for 205776*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;SUBCUTANEOUS |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 205776
| Mechanism of Action | Folic Acid Metabolism Inhibitors |
Medical Subject Heading (MeSH) Categories for 205776
Suppliers and Packaging for NDA: 205776
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RASUVO | methotrexate | SOLUTION;SUBCUTANEOUS | 205776 | NDA | Medexus Pharma Inc. | 59137-505 | 59137-505-01 | 1 PACKAGE in 1 CARTON (59137-505-01) / .15 mL in 1 PACKAGE (59137-505-00) |
| RASUVO | methotrexate | SOLUTION;SUBCUTANEOUS | 205776 | NDA | Medexus Pharma Inc. | 59137-505 | 59137-505-04 | 4 PACKAGE in 1 CARTON (59137-505-04) / .15 mL in 1 PACKAGE (59137-505-00) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;SUBCUTANEOUS | Strength | 7.5MG/0.15ML (7.5MG/0.15ML) | ||||
| Approval Date: | Jul 10, 2014 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jun 1, 2029 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | SUBCUTANEOUS INJECTION OF METHOTREXATE | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;SUBCUTANEOUS | Strength | 10MG/0.20ML (10MG/0.20ML) | ||||
| Approval Date: | Jul 10, 2014 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jun 1, 2029 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | SUBCUTANEOUS INJECTION OF METHOTREXATE | ||||||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;SUBCUTANEOUS | Strength | 12.5MG/0.25ML (12.5MG/0.25ML) | ||||
| Approval Date: | Jul 10, 2014 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jun 1, 2029 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | SUBCUTANEOUS INJECTION OF METHOTREXATE | ||||||||
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