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Details for New Drug Application (NDA): 208400
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 three 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-four 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 are twenty drug master file entries for this compound. Twenty-four 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: | 3 |
| Formulation / Manufacturing: | see details |
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 | 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: | RX | Dosage: | SOLUTION;ORAL | Strength | EQ 2MG BASE/ML | ||||
| Approval Date: | Apr 25, 2017 | TE: | 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: | Start Trial | Patent Expiration: | Jan 2, 2033 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | A METHOD FOR TREATING ACUTE LYMPHOBLASTIC LEUKEMIA | ||||||||
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