Details for New Drug Application (NDA): 212479
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NDA 212479 describes JYLAMVO, which is a drug marketed by Shorla and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the JYLAMVO profile page.
The generic ingredient in JYLAMVO 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 JYLAMVO 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 212479
| Tradename: | JYLAMVO |
| Applicant: | Shorla |
| Ingredient: | methotrexate |
| Patents: | 2 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 212479
| Mechanism of Action | Folic Acid Metabolism Inhibitors |
Medical Subject Heading (MeSH) Categories for 212479
Suppliers and Packaging for NDA: 212479
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| JYLAMVO | methotrexate | SOLUTION;ORAL | 212479 | NDA | SHORLA ONCOLOGY INC. | 81927-204 | 81927-204-01 | 1 BOTTLE, GLASS in 1 CARTON (81927-204-01) / 60 mL in 1 BOTTLE, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 2MG/ML | ||||
| Approval Date: | Nov 29, 2022 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Oct 28, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Oct 29, 2034 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF ADULTS WITH ACUTE LYMPHOBLASTIC LEUKEMIA WITH AN ORAL SOLUTION OF METHOTREXATE | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Oct 29, 2034 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF ADULTS WITH MYCOSIS FUNGOIDES WITH AN ORAL SOLUTION OF METHOTREXATE | ||||||||
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