Details for New Drug Application (NDA): 077087
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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 077087
Tradename: | LEFLUNOMIDE |
Applicant: | Wanbang Biopharms |
Ingredient: | leflunomide |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 077087
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LEFLUNOMIDE | leflunomide | TABLET;ORAL | 077087 | ANDA | Fosun Pharma USA Inc. | 72266-132 | 72266-132-50 | 30 TABLET in 1 BOTTLE (72266-132-50) |
LEFLUNOMIDE | leflunomide | TABLET;ORAL | 077087 | ANDA | Fosun Pharma USA Inc. | 72266-133 | 72266-133-50 | 30 TABLET in 1 BOTTLE (72266-133-50) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Sep 13, 2005 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
Approval Date: | Sep 13, 2005 | TE: | AB | RLD: | No |
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