DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 077086
The generic ingredient in LEFLUNOMIDE is leflunomide. There are six drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the leflunomide profile page.
Summary for 077086
Tradename: | LEFLUNOMIDE |
Applicant: | Heritage Pharms Inc |
Ingredient: | leflunomide |
Patents: | 0 |
Therapeutic Class: | Immunological Agents |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 077086
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LEFLUNOMIDE | leflunomide | TABLET;ORAL | 077086 | ANDA | Heritage Pharmaceuticals Inc | 23155-043 | N | 23155-043-05 |
LEFLUNOMIDE | leflunomide | TABLET;ORAL | 077086 | ANDA | Heritage Pharmaceuticals Inc | 23155-043 | N | 23155-043-03 |
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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