Details for New Drug Application (NDA): 209623
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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 209623
Tradename: | TERIFLUNOMIDE |
Applicant: | Msn |
Ingredient: | teriflunomide |
Patents: | 0 |
Pharmacology for NDA: 209623
Mechanism of Action | Dihydroorotate Dehydrogenase Inhibitors |
Suppliers and Packaging for NDA: 209623
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TERIFLUNOMIDE | teriflunomide | TABLET;ORAL | 209623 | ANDA | Dr. Reddy's Laboratories Inc | 43598-281 | 43598-281-30 | 30 TABLET, FILM COATED in 1 BOTTLE (43598-281-30) |
TERIFLUNOMIDE | teriflunomide | TABLET;ORAL | 209623 | ANDA | MSN LABORATORIES PRIVATE LIMITED | 69539-032 | 69539-032-41 | 2 BLISTER PACK in 1 CARTON (69539-032-41) / 14 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 7MG | ||||
Approval Date: | Apr 24, 2019 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 14MG | ||||
Approval Date: | Apr 24, 2019 | TE: | AB | RLD: | No |
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