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Generated: November 14, 2018

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Details for New Drug Application (NDA): 208400

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NDA 208400 describes XATMEP, which is a drug marketed by Silvergate Pharms 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 XATMEP profile page.

The generic ingredient in XATMEP is methotrexate sodium. There are twenty drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the methotrexate sodium profile page.
Summary for 208400
Tradename:XATMEP
Applicant:Silvergate Pharms
Ingredient:methotrexate sodium
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 208400
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 Silvergate Pharmaceuticals, Inc. 52652-2001 52652-2001-1 120 mL in 1 BOTTLE (52652-2001-1)
XATMEP methotrexate sodium SOLUTION;ORAL 208400 NDA Silvergate Pharmaceuticals, Inc. 52652-2001 52652-2001-6 60 mL in 1 BOTTLE (52652-2001-6)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrengthEQ 2MG BASE/ML
Approval Date:Apr 25, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Apr 25, 2024
Regulatory Exclusivity Use:TREATMENT OF OLIGOARTICULAR JUVENILE IDIOPATHIC ARTHRITIS (PERSISTENT OLIGOARTHRITIS, PSORIATIC JUVENILE IDIOPATHIC ARTHRITIS, ENTHESITIS-RELATED ARTHRITIS, OR UNDIFFERENTIATED ARTHRITIS) & POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS IN CHILDREN 0-16 YRS
Regulatory Exclusivity Expiration:Apr 25, 2024
Regulatory Exclusivity Use:TREATMENT OF PEDIATRIC PATIENTS WITH ACUTE LYMPHOBLASTIC LEUKEMIA AS A COMPONENT OF A COMBINATION CHEOMOTHERAPY MAINTENANCE REGIMEN
Patent:➤ Sign UpPatent Expiration:Jan 2, 2033Product Flag?YSubstance Flag?Delist Request?

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