Details for New Drug Application (NDA): 213652
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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 213652
Tradename: | LEFLUNOMIDE |
Applicant: | Aurobindo Pharma |
Ingredient: | leflunomide |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 213652
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LEFLUNOMIDE | leflunomide | TABLET;ORAL | 213652 | ANDA | A-S Medication Solutions | 50090-5992 | 50090-5992-0 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-5992-0) |
LEFLUNOMIDE | leflunomide | TABLET;ORAL | 213652 | ANDA | Aurobindo Pharma Limited | 59651-348 | 59651-348-30 | 30 TABLET, FILM COATED in 1 BOTTLE (59651-348-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Mar 29, 2021 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
Approval Date: | Mar 29, 2021 | TE: | AB | RLD: | No |
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