Details for New Drug Application (NDA): 209702
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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 209702
Tradename: | TERIFLUNOMIDE |
Applicant: | Mylan |
Ingredient: | teriflunomide |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 209702
Mechanism of Action | Dihydroorotate Dehydrogenase Inhibitors |
Suppliers and Packaging for NDA: 209702
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TERIFLUNOMIDE | teriflunomide | TABLET;ORAL | 209702 | ANDA | Mylan Pharmaceuticals Inc. | 0378-0627 | 0378-0627-93 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0627-93) |
TERIFLUNOMIDE | teriflunomide | TABLET;ORAL | 209702 | ANDA | Mylan Pharmaceuticals Inc. | 0378-0628 | 0378-0628-93 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0628-93) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 7MG | ||||
Approval Date: | Feb 28, 2020 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 14MG | ||||
Approval Date: | Feb 28, 2020 | TE: | RLD: | No |
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