leflunomide is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Zydus Pharmaceuticals (usa) Inc.. The primary component is Leflunomide.
Product ID | 70710-1157_c9906419-d11a-4520-9f2d-88b94e622fe5 |
NDC | 70710-1157 |
Product Type | Human Prescription Drug |
Proprietary Name | leflunomide |
Generic Name | Leflunomide |
Dosage Form | Tablet, Film Coated |
Route of Administration | ORAL |
Marketing Start Date | 2019-04-26 |
Marketing Category | ANDA / ANDA |
Application Number | ANDA212308 |
Labeler Name | Zydus Pharmaceuticals (USA) Inc. |
Substance Name | LEFLUNOMIDE |
Active Ingredient Strength | 10 mg/1 |
Pharm Classes | Antirheumatic Agent [EPC] |
NDC Exclude Flag | N |
Listing Certified Through | 2020-12-31 |
Marketing Start Date | 2019-04-26 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | ANDA |
Application Number | ANDA212308 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | EA |
Marketing Start Date | 2019-04-26 |
Marketing Category | ANDA |
Application Number | ANDA212308 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2019-04-26 |
Marketing Category | ANDA |
Application Number | ANDA212308 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2019-04-26 |
Ingredient | Strength |
---|---|
LEFLUNOMIDE | 10 mg/1 |
NDC | Brand Name | Generic Name |
---|---|---|
0955-1735 | Leflunomide | leflunomide |
0955-1737 | Leflunomide | leflunomide |
10702-277 | Leflunomide | Leflunomide |
10702-278 | Leflunomide | Leflunomide |
13811-677 | Leflunomide | Leflunomide |
13811-678 | Leflunomide | Leflunomide |
23155-043 | Leflunomide | Leflunomide |
68258-2992 | Leflunomide | Leflunomide |
23155-044 | Leflunomide | Leflunomide |
46708-437 | Leflunomide | Leflunomide |
46708-436 | Leflunomide | Leflunomide |
60505-2503 | LEFLUNOMIDE | LEFLUNOMIDE |
60505-2502 | LEFLUNOMIDE | LEFLUNOMIDE |
62332-062 | Leflunomide | Leflunomide |
62332-061 | Leflunomide | Leflunomide |
70710-1157 | leflunomide | leflunomide |
70710-1158 | leflunomide | leflunomide |
70771-1492 | leflunomide | leflunomide |
70771-1491 | leflunomide | leflunomide |
42291-420 | LEFLUNOMIDE | LEFLUNOMIDE |
42291-421 | LEFLUNOMIDE | LEFLUNOMIDE |
70748-130 | Leflunomide | Leflunomide |
70748-129 | Leflunomide | Leflunomide |
50268-477 | LEFLUNOMIDE | LEFLUNOMIDE |
50268-478 | LEFLUNOMIDE | LEFLUNOMIDE |
0088-2160 | Arava | leflunomide |
0088-2161 | Arava | leflunomide |
0088-2162 | Arava | leflunomide |