Details for New Drug Application (NDA): 209583
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The generic ingredient in TERIFLUNOMIDE is teriflunomide. There are nineteen drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the teriflunomide profile page.
Summary for 209583
Tradename: | TERIFLUNOMIDE |
Applicant: | Breckenridge |
Ingredient: | teriflunomide |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 209583
Mechanism of Action | Dihydroorotate Dehydrogenase Inhibitors |
Suppliers and Packaging for NDA: 209583
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TERIFLUNOMIDE | teriflunomide | TABLET;ORAL | 209583 | ANDA | Breckenridge Pharmaceutical, Inc. | 51991-881 | 51991-881-28 | 28 BLISTER PACK in 1 CARTON (51991-881-28) / 28 TABLET in 1 BLISTER PACK |
TERIFLUNOMIDE | teriflunomide | TABLET;ORAL | 209583 | ANDA | Breckenridge Pharmaceutical, Inc. | 51991-881 | 51991-881-90 | 90 TABLET in 1 BOTTLE (51991-881-90) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 7MG | ||||
Approval Date: | Sep 24, 2021 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 14MG | ||||
Approval Date: | Sep 24, 2021 | TE: | RLD: | No |
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