Details for New Drug Application (NDA): 212453
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The generic ingredient in LEFLUNOMIDE is leflunomide. There are seven drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the leflunomide profile page.
Summary for 212453
Tradename: | LEFLUNOMIDE |
Applicant: | Abhai Llc |
Ingredient: | leflunomide |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Jun 3, 2019 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
Approval Date: | Jun 3, 2019 | TE: | AB | RLD: | No |
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