Details for New Drug Application (NDA): 208400
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The generic ingredient in XATMEP is methotrexate sodium. There are twenty drug master file entries 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: | 6 |
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: | ⤷ Try for Free | Patent Expiration: | Jan 2, 2033 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | A METHOD FOR TREATING ACUTE LYMPHOBLASTIC LEUKEMIA | ||||||||
Patent: | ⤷ Try for Free | Patent Expiration: | Jan 2, 2033 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF JUVENILE RHEUMATOID ARTHRITIS | ||||||||
Patent: | ⤷ Try for Free | Patent Expiration: | Jan 2, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? |
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