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 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A216848-001 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | 2022-11-03 | ||
| A216848-002 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | 2022-11-03 | ||
| A216848-003 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | 2022-11-03 | ||
| A216848-004 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | 2022-11-03 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A216848-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | 2022-11-03 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A216848-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | 2022-11-03 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A216848-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | 2022-11-03 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A216848-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | 2022-11-03 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216848-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | 2022-11-03 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216848-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | 2022-11-03 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216848-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | 2022-11-03 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216848-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | 2022-11-03 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A216848-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | 2022-11-03 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A216848-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | 2022-11-03 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A216848-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | 2022-11-03 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A216848-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | 2022-11-03 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216848-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | 2022-11-03 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216848-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | 2022-11-03 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216848-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | 2022-11-03 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216848-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | 2022-11-03 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216848-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | 2022-11-03 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216848-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | 2022-11-03 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216848-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | 2022-11-03 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216848-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | 2022-11-03 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216848-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | 2022-11-03 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216848-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | 2022-11-03 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216848-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | 2022-11-03 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216848-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | 2022-11-03 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216848-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | 2022-11-03 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216848-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | 2022-11-03 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216848-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | 2022-11-03 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216848-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | 2022-11-03 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216848-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | 2022-11-03 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216848-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | 2022-11-03 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216848-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | 2022-11-03 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216848-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | 2022-11-03 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216848-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | 2022-11-03 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216848-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | 2022-11-03 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216848-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | 2022-11-03 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216848-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | 2022-11-03 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A216848-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | 2022-11-03 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A216848-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | 2022-11-03 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A216848-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | 2022-11-03 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A216848-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | 2022-11-03 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2023-05-13 08:27 UTC | 2023-05 | A216848-001 | AB | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A216848-002 | AB | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A216848-003 | AB | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A216848-004 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A216848-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A216848-002 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A216848-003 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A216848-004 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A216848-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A216848-002 | AB | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A216848-003 | AB | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A216848-004 | AB | 1 | 3a93d1ddd44b… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| atorvastatin calcium | ATORVASTATIN CALCIUM | Lepu Pharmaceutical Technology Co., Ltd. | 173474b6-26b4-46f2-a12a-64753ae5e905 | 2025-10-29 | Warnings, Adverse reactions | 216848 ANDA216848 82137-016 82137-017 82137-019 82137-018 |
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 |