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Application 090383
- Type
- ANDA
- Sponsor
- MICRO LABS
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 |
|---|
| 42571-005 | Simvastatin | Simvastatin | Micro Labs Limited | ANDA | Current |
| 42571-005 | Simvastatin | Simvastatin | Micro Labs Limited | ANDA | Current |
| 42571-005 | Simvastatin | Simvastatin | Micro Labs Limited | ANDA | Current |
| 42571-005 | Simvastatin | Simvastatin | Micro Labs Limited | ANDA | Current |
| 42571-005 | Simvastatin | Simvastatin | Micro Labs Limited | ANDA | Current |
| 42571-005 | Simvastatin | Simvastatin | Micro Labs Limited | ANDA | Current |
| 42571-005 | Simvastatin | Simvastatin | Micro Labs Limited | ANDA | Current |
| 42571-010 | Simvastatin | Simvastatin | Micro Labs Limited | ANDA | Current |
| 42571-010 | Simvastatin | Simvastatin | Micro Labs Limited | ANDA | Current |
| 42571-010 | Simvastatin | Simvastatin | Micro Labs Limited | ANDA | Current |
| 42571-010 | Simvastatin | Simvastatin | Micro Labs Limited | ANDA | Current |
| 42571-010 | Simvastatin | Simvastatin | Micro Labs Limited | ANDA | Current |
| 42571-010 | Simvastatin | Simvastatin | Micro Labs Limited | ANDA | Current |
| 42571-010 | Simvastatin | Simvastatin | Micro Labs Limited | ANDA | Current |
| 42571-020 | Simvastatin | Simvastatin | Micro Labs Limited | ANDA | Current |
| 42571-020 | Simvastatin | Simvastatin | Micro Labs Limited | ANDA | Current |
| 42571-020 | Simvastatin | Simvastatin | Micro Labs Limited | ANDA | Current |
| 42571-020 | Simvastatin | Simvastatin | Micro Labs Limited | ANDA | Current |
| 42571-020 | Simvastatin | Simvastatin | Micro Labs Limited | ANDA | Current |
| 42571-020 | Simvastatin | Simvastatin | Micro Labs Limited | ANDA | Current |
| 42571-020 | Simvastatin | Simvastatin | Micro Labs Limited | ANDA | Current |
| 42571-040 | Simvastatin | Simvastatin | Micro Labs Limited | ANDA | Current |
| 42571-040 | Simvastatin | Simvastatin | Micro Labs Limited | ANDA | Current |
| 42571-040 | Simvastatin | Simvastatin | Micro Labs Limited | ANDA | Current |
| 42571-040 | Simvastatin | Simvastatin | Micro Labs Limited | ANDA | Current |
| 42571-040 | Simvastatin | Simvastatin | Micro Labs Limited | ANDA | Current |
| 42571-040 | Simvastatin | Simvastatin | Micro Labs Limited | ANDA | Current |
| 42571-040 | Simvastatin | Simvastatin | Micro Labs Limited | ANDA | Current |
| 42571-080 | Simvastatin | Simvastatin | Micro Labs Limited | ANDA | Current |
| 42571-080 | Simvastatin | Simvastatin | Micro Labs Limited | ANDA | Current |
| 42571-080 | Simvastatin | Simvastatin | Micro Labs Limited | ANDA | Current |
| 42571-080 | Simvastatin | Simvastatin | Micro Labs Limited | ANDA | Current |
| 42571-080 | Simvastatin | Simvastatin | Micro Labs Limited | ANDA | Current |
| 42571-080 | Simvastatin | Simvastatin | Micro Labs Limited | ANDA | Current |
| 42571-080 | Simvastatin | Simvastatin | Micro Labs Limited | ANDA | Current |