Application 216848
- Type
- ANDA
- Sponsor
- LEPU PHARM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | TABLET;ORAL | EQ 10MG BASE | No | No |
| 002 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | TABLET;ORAL | EQ 20MG BASE | No | No |
| 003 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | TABLET;ORAL | EQ 40MG BASE | No | No |
| 004 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | TABLET;ORAL | EQ 80MG BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 82137-016 | atorvastatin calcium | atorvastatin calcium | Lepu Pharmaceutical Technology Co., Ltd. | ANDA | Current |
| 82137-017 | atorvastatin calcium | atorvastatin calcium | Lepu Pharmaceutical Technology Co., Ltd. | ANDA | Current |
| 82137-018 | atorvastatin calcium | atorvastatin calcium | Lepu Pharmaceutical Technology Co., Ltd. | ANDA | Current |
| 82137-019 | atorvastatin calcium | atorvastatin calcium | Lepu Pharmaceutical Technology Co., Ltd. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 84046 | ORIG | 2025-11-04 |