Details for New Drug Application (NDA): 208400
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NDA 208400 describes XATMEP, which is a drug marketed by Azurity and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug. Additional details are available on the XATMEP profile page.
The generic ingredient in XATMEP is methotrexate sodium. There is one drug master file entry for this compound. Thirty suppliers are listed for this compound. Additional details are available on the methotrexate sodium profile page.
The generic ingredient in XATMEP is methotrexate sodium. There is one drug master file entry for this compound. Thirty suppliers are listed for this compound. Additional details are available on the methotrexate sodium profile page.
Summary for 208400
| Tradename: | XATMEP |
| Applicant: | Azurity |
| Ingredient: | methotrexate sodium |
| Patents: | 7 |
Pharmacology for NDA: 208400
| Mechanism of Action | Folic Acid Metabolism Inhibitors |
Suppliers and Packaging for NDA: 208400
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| XATMEP | methotrexate sodium | SOLUTION;ORAL | 208400 | NDA | Azurity Pharmaceuticals, Inc. | 52652-2001 | 52652-2001-1 | 120 mL in 1 BOTTLE (52652-2001-1) |
| XATMEP | methotrexate sodium | SOLUTION;ORAL | 208400 | NDA | Azurity Pharmaceuticals, Inc. | 52652-2001 | 52652-2001-6 | 60 mL in 1 BOTTLE (52652-2001-6) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | EQ 2.5MG BASE/ML | ||||
| Approval Date: | Apr 25, 2017 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jan 2, 2033 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | A METHOD FOR TREATING ACUTE LYMPHOBLASTIC LEUKEMIA | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jan 2, 2033 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF JUVENILE RHEUMATOID ARTHRITIS | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jan 2, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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