Application 203367
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | TABLET;ORAL | 10MG | No | No |
| 002 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | TABLET;ORAL | 20MG | No | No |
| 003 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | TABLET;ORAL | 40MG | No | No |
| 004 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | TABLET;ORAL | 80MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 57237-164 | Pravastatin sodium | Pravastatin sodium | Rising Health, LLC | ANDA | Current |
| 57237-164 | Pravastatin sodium | Pravastatin sodium | Rising Health, LLC | ANDA | Current |
| 57237-164 | Pravastatin sodium | Pravastatin sodium | Rising Health, LLC | ANDA | Current |
| 57237-164 | Pravastatin sodium | Pravastatin sodium | Rising Health, LLC | ANDA | Current |
| 57237-165 | Pravastatin sodium | Pravastatin sodium | Rising Health, LLC | ANDA | Current |
| 57237-165 | Pravastatin sodium | Pravastatin sodium | Rising Health, LLC | ANDA | Current |
| 57237-165 | Pravastatin sodium | Pravastatin sodium | Rising Health, LLC | ANDA | Current |
| 57237-165 | Pravastatin sodium | Pravastatin sodium | Rising Health, LLC | ANDA | Current |
| 57237-166 | Pravastatin sodium | Pravastatin sodium | Rising Health, LLC | ANDA | Current |
| 57237-166 | Pravastatin sodium | Pravastatin sodium | Rising Health, LLC | ANDA | Current |
| 57237-166 | Pravastatin sodium | Pravastatin sodium | Rising Health, LLC | ANDA | Current |
| 57237-166 | Pravastatin sodium | Pravastatin sodium | Rising Health, LLC | ANDA | Current |
| 57237-167 | Pravastatin sodium | Pravastatin sodium | Rising Health, LLC | ANDA | Current |
| 57237-167 | Pravastatin sodium | Pravastatin sodium | Rising Health, LLC | ANDA | Current |
| 57237-167 | Pravastatin sodium | Pravastatin sodium | Rising Health, LLC | ANDA | Current |
| 57237-167 | Pravastatin sodium | Pravastatin sodium | Rising Health, LLC | ANDA | Current |
| 65862-632 | Pravastatin sodium | Pravastatin sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-632 | Pravastatin sodium | Pravastatin sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-632 | Pravastatin sodium | Pravastatin sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-632 | Pravastatin sodium | Pravastatin sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-632 | Pravastatin sodium | Pravastatin sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-633 | Pravastatin sodium | Pravastatin sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-633 | Pravastatin sodium | Pravastatin sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-633 | Pravastatin sodium | Pravastatin sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-633 | Pravastatin sodium | Pravastatin sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-633 | Pravastatin sodium | Pravastatin sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-634 | Pravastatin sodium | Pravastatin sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-634 | Pravastatin sodium | Pravastatin sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-634 | Pravastatin sodium | Pravastatin sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-634 | Pravastatin sodium | Pravastatin sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-634 | Pravastatin sodium | Pravastatin sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-635 | Pravastatin sodium | Pravastatin sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-635 | Pravastatin sodium | Pravastatin sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-635 | Pravastatin sodium | Pravastatin sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-635 | Pravastatin sodium | Pravastatin sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-635 | Pravastatin sodium | Pravastatin sodium | Aurobindo Pharma Limited | ANDA | Current |
| 68071-4894 | Pravastatin sodium | Pravastatin sodium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4894 | Pravastatin sodium | Pravastatin sodium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 70518-1731 | Pravastatin sodium | Pravastatin sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-1731 | Pravastatin sodium | Pravastatin sodium | REMEDYREPACK INC. | ANDA | Current |