Details for New Drug Application (NDA): 212308
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The generic ingredient in LEFLUNOMIDE is leflunomide. There are seven drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the leflunomide profile page.
Summary for 212308
Tradename: | LEFLUNOMIDE |
Applicant: | Zydus Lifesciences |
Ingredient: | leflunomide |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 212308
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LEFLUNOMIDE | leflunomide | TABLET;ORAL | 212308 | ANDA | Zydus Pharmaceuticals (USA) Inc. | 70710-1157 | 70710-1157-1 | 100 TABLET, FILM COATED in 1 BOTTLE (70710-1157-1) |
LEFLUNOMIDE | leflunomide | TABLET;ORAL | 212308 | ANDA | Zydus Pharmaceuticals (USA) Inc. | 70710-1157 | 70710-1157-3 | 30 TABLET, FILM COATED in 1 BOTTLE (70710-1157-3) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Apr 24, 2019 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
Approval Date: | Apr 24, 2019 | TE: | AB | RLD: | No |
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