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. Eighteen 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 |
Suppliers and Packaging for NDA: 212453
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LEFLUNOMIDE | leflunomide | TABLET;ORAL | 212453 | ANDA | KVK-Tech, Inc. | 10702-277 | 10702-277-03 | 30 TABLET in 1 BOTTLE (10702-277-03) |
LEFLUNOMIDE | leflunomide | TABLET;ORAL | 212453 | ANDA | KVK-Tech, Inc. | 10702-278 | 10702-278-03 | 30 TABLET in 1 BOTTLE (10702-278-03) |
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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