Details for New Drug Application (NDA): 209555
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The generic ingredient in TERIFLUNOMIDE is teriflunomide. There are nineteen drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the teriflunomide profile page.
Summary for 209555
Tradename: | TERIFLUNOMIDE |
Applicant: | Natco |
Ingredient: | teriflunomide |
Patents: | 0 |
Pharmacology for NDA: 209555
Mechanism of Action | Dihydroorotate Dehydrogenase Inhibitors |
Suppliers and Packaging for NDA: 209555
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TERIFLUNOMIDE | teriflunomide | TABLET;ORAL | 209555 | ANDA | Natco Pharma USA LLC | 69339-169 | 69339-169-03 | 30 TABLET in 1 BOTTLE (69339-169-03) |
TERIFLUNOMIDE | teriflunomide | TABLET;ORAL | 209555 | ANDA | Natco Pharma USA LLC | 69339-169 | 69339-169-09 | 90 TABLET in 1 BOTTLE (69339-169-09) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 7MG | ||||
Approval Date: | May 15, 2023 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 14MG | ||||
Approval Date: | May 15, 2023 | TE: | AB | RLD: | No |
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