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Application 077904
- Type
- ANDA
- Sponsor
- CIPLA
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 |
|---|
| 69097-183 | Pravastatin Sodium | Pravastatin Sodium | Cipla USA Inc. | ANDA | Current |
| 69097-184 | Pravastatin Sodium | Pravastatin Sodium | Cipla USA Inc. | ANDA | Current |
| 69097-185 | Pravastatin Sodium | Pravastatin Sodium | Cipla USA Inc. | ANDA | Current |
| 69097-186 | Pravastatin Sodium | Pravastatin Sodium | Cipla USA Inc. | ANDA | Current |