Details for New Drug Application (NDA): 213497
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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 213497
Tradename: | LEFLUNOMIDE |
Applicant: | Aet Pharma |
Ingredient: | leflunomide |
Patents: | 0 |
Suppliers and Packaging for NDA: 213497
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LEFLUNOMIDE | leflunomide | TABLET;ORAL | 213497 | ANDA | Burel Pharmaceuticals, LLC | 35573-447 | 35573-447-30 | 30 TABLET, FILM COATED in 1 BOTTLE (35573-447-30) |
LEFLUNOMIDE | leflunomide | TABLET;ORAL | 213497 | ANDA | Burel Pharmaceuticals, LLC | 35573-448 | 35573-448-30 | 30 TABLET, FILM COATED in 1 BOTTLE (35573-448-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | May 10, 2021 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
Approval Date: | May 10, 2021 | TE: | AB | RLD: | No |
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