Application 076285
- Type
- ANDA
- Sponsor
- SUN PHARM INDS LTD
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 |
|---|
| 53808-0793 | Simvastatin | SIMVASTATIN | State of Florida DOH Central Pharmacy | ANDA | Current |
| 63304-789 | Simvastatin | simvastatin | Ranbaxy Pharmaceuticals Inc. | ANDA | Current |
| 63304-790 | Simvastatin | simvastatin | Ranbaxy Pharmaceuticals Inc. | ANDA | Current |
| 63304-791 | Simvastatin | simvastatin | Ranbaxy Pharmaceuticals Inc. | ANDA | Current |
| 63304-792 | Simvastatin | simvastatin | Ranbaxy Pharmaceuticals Inc. | ANDA | Current |
| 63304-793 | Simvastatin | simvastatin | Ranbaxy Pharmaceuticals Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 44299 | ORIG | 2011-05-26 |
| 8886 | ORIG | 2006-06-27 |