Application 076714
- Type
- ANDA
- Sponsor
- DR REDDYS LABS INC
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 |
|---|
| 0615-7570 | Pravastatin | Pravastatin Sodium | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 43063-143 | Pravastatin sodium | Pravastatin sodium | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-143 | Pravastatin sodium | Pravastatin sodium | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-143 | Pravastatin sodium | Pravastatin sodium | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55111-229 | Pravastatin sodium | Pravastatin sodium | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-230 | Pravastatin sodium | Pravastatin sodium | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-231 | Pravastatin sodium | Pravastatin sodium | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-274 | Pravastatin sodium | Pravastatin sodium | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 68788-7193 | Pravastatin sodium | Pravastatin sodium | Preferred Pharmaceuticals Inc. | ANDA | Current |