Application 202726
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | GEMFIBROZIL | GEMFIBROZIL | TABLET;ORAL | 600MG | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0615-8354 | Gemfibrozil | Gemfibrozil | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | Current |
| 0615-8354 | Gemfibrozil | Gemfibrozil | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 16571-784 | Gemfibrozil | Gemfibrozil | Rising Pharma Holdings, Inc. | ANDA | Current |
| 16571-784 | Gemfibrozil | Gemfibrozil | Rising Pharma Holdings, Inc. | ANDA | Current |
| 50090-2450 | Gemfibrozil | Gemfibrozil | A-S Medication Solutions | ANDA | Current |
| 53002-2068 | Gemfibrozil | Gemfibrozil | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-2068 | Gemfibrozil | Gemfibrozil | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 57237-163 | Gemfibrozil | Gemfibrozil | Rising Health, LLC | ANDA | Current |
| 57237-163 | Gemfibrozil | Gemfibrozil | Rising Health, LLC | ANDA | Current |
| 57237-163 | Gemfibrozil | Gemfibrozil | Rising Health, LLC | ANDA | Current |
| 65862-624 | Gemfibrozil | Gemfibrozil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-624 | Gemfibrozil | Gemfibrozil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-624 | Gemfibrozil | Gemfibrozil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-624 | Gemfibrozil | Gemfibrozil | Aurobindo Pharma Limited | ANDA | Current |
| 68071-4631 | Gemfibrozil | Gemfibrozil | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 71205-169 | Gemfibrozil | Gemfibrozil | Proficient Rx LP | ANDA | Current |
| 71205-169 | Gemfibrozil | Gemfibrozil | Proficient Rx LP | ANDA | Current |
| 71335-0899 | Gemfibrozil | Gemfibrozil | Bryant Ranch Prepack | ANDA | Current |
| 71335-0899 | Gemfibrozil | Gemfibrozil | Bryant Ranch Prepack | ANDA | Current |
| 71335-0899 | Gemfibrozil | Gemfibrozil | Bryant Ranch Prepack | ANDA | Current |
| 71335-2025 | Gemfibrozil | Gemfibrozil | Bryant Ranch Prepack | ANDA | Current |
| 71335-2025 | Gemfibrozil | Gemfibrozil | Bryant Ranch Prepack | ANDA | Current |