Application 076052
- Type
- ANDA
- Sponsor
- IVAX SUB TEVA PHARMS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | SIMVASTATIN | SIMVASTATIN | TABLET;ORAL | 5MG | No | No |
| 002 | SIMVASTATIN | SIMVASTATIN | TABLET;ORAL | 10MG | No | No |
| 003 | SIMVASTATIN | SIMVASTATIN | TABLET;ORAL | 20MG | No | No |
| 004 | SIMVASTATIN | SIMVASTATIN | TABLET;ORAL | 40MG | No | No |
| 005 | SIMVASTATIN | SIMVASTATIN | TABLET;ORAL | 80MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0093-7152 | Simvastatin | Simvastatin | Teva Pharmaceuticals USA, | ANDA | Current |
| 0093-7152 | Simvastatin | Simvastatin | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7153 | Simvastatin | Simvastatin | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7153 | Simvastatin | Simvastatin | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7153 | Simvastatin | Simvastatin | Teva Pharmaceuticals USA, | ANDA | Current |
| 0093-7154 | Simvastatin | Simvastatin | Teva Pharmaceuticals USA, | ANDA | Current |
| 0093-7154 | Simvastatin | Simvastatin | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7154 | Simvastatin | Simvastatin | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7155 | Simvastatin | Simvastatin | Teva Pharmaceuticals USA, | ANDA | Current |
| 0093-7155 | Simvastatin | Simvastatin | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7155 | Simvastatin | Simvastatin | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7156 | Simvastatin | Simvastatin | Teva Pharmaceuticals USA, | ANDA | Current |
| 0093-7156 | Simvastatin | Simvastatin | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0179-0128 | Simvastatin | Simvastatin | KAISER FOUNDATION HOSPITALS | ANDA | Current |
| 0179-1897 | Simvastatin | Simvastatin | KAISER FOUNDATION HOSPITALS | ANDA | Current |
| 0179-1898 | Simvastatin | Simvastatin | KAISER FOUNDATION HOSPITALS | ANDA | Current |
| 0179-1899 | Simvastatin | Simvastatin | KAISER FOUNDATION HOSPITALS | ANDA | Current |
| 42708-051 | Simvastatin | Simvastatin | QPharma Inc | ANDA | Current |
| 42708-051 | Simvastatin | Simvastatin | QPharma Inc | ANDA | Current |
| 42708-052 | Simvastatin | Simvastatin | QPharma Inc | ANDA | Current |
| 42708-052 | Simvastatin | Simvastatin | QPharma Inc | ANDA | Current |
| 51079-454 | Simvastatin | Simvastatin | Mylan Institutional Inc. | ANDA | Current |
| 51079-454 | Simvastatin | Simvastatin | Mylan Institutional Inc. | ANDA | Current |
| 51079-455 | Simvastatin | Simvastatin | Mylan Institutional Inc. | ANDA | Current |
| 51079-455 | Simvastatin | Simvastatin | Mylan Institutional Inc. | ANDA | Current |
| 51079-456 | Simvastatin | Simvastatin | Mylan Institutional Inc. | ANDA | Current |
| 51079-456 | Simvastatin | Simvastatin | Mylan Institutional Inc. | ANDA | Current |
| 53808-0792 | Simvastatin | Simvastatin | State of Florida DOH Central Pharmacy | ANDA | Current |
| 54458-932 | Simvastatin | Simvastatin | International Laboratories, LLC | ANDA | Current |
| 54458-932 | Simvastatin | Simvastatin | International Laboratories, LLC | ANDA | Current |
| 54458-933 | Simvastatin | Simvastatin | International Laboratories, LLC | ANDA | Current |
| 54458-933 | Simvastatin | Simvastatin | International Laboratories, LLC | ANDA | Current |
| 54458-934 | Simvastatin | Simvastatin | International Laboratories, LLC | ANDA | Current |
| 54458-934 | Simvastatin | Simvastatin | International Laboratories, LLC | ANDA | Current |
| 55289-293 | Simvastatin | Simvastatin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-293 | Simvastatin | Simvastatin | PD-Rx Pharmaceuticals, In | ANDA | Current |
| 55289-338 | Simvastatin | Simvastatin | PD-Rx Pharmaceuticals, In | ANDA | Current |
| 55289-338 | Simvastatin | Simvastatin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 66116-316 | Simvastatin | Simvastatin | MedVantx, Inc. | ANDA | Current |
| 68071-3157 | Simvastatin | Simvastatin | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68151-0177 | Simvastatin | Simvastatin | Carilion Materials Management | ANDA | Current |
| 68788-7437 | Simvastatin | Simvastatin | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 71205-070 | Simvastatin | Simvastatin | Proficient Rx LP | ANDA | Current |
| 71205-070 | Simvastatin | Simvastatin | Proficient Rx LP | ANDA | Current |
| 71335-1020 | Simvastatin | Simvastatin | Bryant Ranch Prepack | ANDA | Current |
| 71335-1020 | Simvastatin | Simvastatin | Bryant Ranch Prepack | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 23796 | ORIG | 2011-05-26 |
| 31066 | ORIG | 2006-06-27 |