Application 020702
- Type
- NDA
- Sponsor
- PFIZER
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LIPITOR | ATORVASTATIN CALCIUM | TABLET;ORAL | EQ 10MG BASE | Yes | No |
| 002 | LIPITOR | ATORVASTATIN CALCIUM | TABLET;ORAL | EQ 20MG BASE | Yes | No |
| 003 | LIPITOR | ATORVASTATIN CALCIUM | TABLET;ORAL | EQ 40MG BASE | Yes | No |
| 004 | LIPITOR | ATORVASTATIN CALCIUM | TABLET;ORAL | EQ 80MG BASE | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020702-001 | LIPITOR | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | RLD | 1996-12-17 |
| N020702-002 | LIPITOR | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | RLD | 1996-12-17 |
| N020702-003 | LIPITOR | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | RLD | 1996-12-17 |
| N020702-004 | LIPITOR | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | AB | RLD, RS | 2000-04-07 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N020702-001 | AB |
| N020702-002 | AB |
| N020702-003 | AB |
| N020702-004 | AB |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N020702-001 | LIPITOR | EQ 10MG BASE | TABLET / ORAL | AB | RLD | 1996-12-17 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N020702-002 | LIPITOR | EQ 20MG BASE | TABLET / ORAL | AB | RLD | 1996-12-17 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N020702-003 | LIPITOR | EQ 40MG BASE | TABLET / ORAL | AB | RLD | 1996-12-17 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N020702-004 | LIPITOR | EQ 80MG BASE | TABLET / ORAL | AB | RLD, RS | 2000-04-07 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N020702-001 | LIPITOR | EQ 10MG BASE | TABLET / ORAL | AB | RLD | 1996-12-17 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020702-002 | LIPITOR | EQ 20MG BASE | TABLET / ORAL | AB | RLD | 1996-12-17 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020702-003 | LIPITOR | EQ 40MG BASE | TABLET / ORAL | AB | RLD | 1996-12-17 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020702-004 | LIPITOR | EQ 80MG BASE | TABLET / ORAL | AB | RLD, RS | 2000-04-07 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020702-001 | LIPITOR | EQ 10MG BASE | TABLET / ORAL | AB | RLD | 1996-12-17 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020702-002 | LIPITOR | EQ 20MG BASE | TABLET / ORAL | AB | RLD | 1996-12-17 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020702-003 | LIPITOR | EQ 40MG BASE | TABLET / ORAL | AB | RLD | 1996-12-17 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020702-004 | LIPITOR | EQ 80MG BASE | TABLET / ORAL | AB | RLD, RS | 2000-04-07 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N020702-001 | LIPITOR | EQ 10MG BASE | TABLET / ORAL | AB | RLD | 1996-12-17 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020702-002 | LIPITOR | EQ 20MG BASE | TABLET / ORAL | AB | RLD | 1996-12-17 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020702-003 | LIPITOR | EQ 40MG BASE | TABLET / ORAL | AB | RLD | 1996-12-17 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020702-004 | LIPITOR | EQ 80MG BASE | TABLET / ORAL | AB | RLD, RS | 2000-04-07 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020702-001 | LIPITOR | EQ 10MG BASE | TABLET / ORAL | AB | RLD | 1996-12-17 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020702-002 | LIPITOR | EQ 20MG BASE | TABLET / ORAL | AB | RLD | 1996-12-17 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020702-003 | LIPITOR | EQ 40MG BASE | TABLET / ORAL | AB | RLD | 1996-12-17 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020702-004 | LIPITOR | EQ 80MG BASE | TABLET / ORAL | AB | RLD, RS | 2000-04-07 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020702-001 | LIPITOR | EQ 10MG BASE | TABLET / ORAL | AB | RLD | 1996-12-17 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020702-002 | LIPITOR | EQ 20MG BASE | TABLET / ORAL | AB | RLD | 1996-12-17 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020702-003 | LIPITOR | EQ 40MG BASE | TABLET / ORAL | AB | RLD | 1996-12-17 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020702-004 | LIPITOR | EQ 80MG BASE | TABLET / ORAL | AB | RLD, RS | 2000-04-07 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020702-001 | LIPITOR | EQ 10MG BASE | TABLET / ORAL | AB | RLD | 1996-12-17 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020702-002 | LIPITOR | EQ 20MG BASE | TABLET / ORAL | AB | RLD | 1996-12-17 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020702-003 | LIPITOR | EQ 40MG BASE | TABLET / ORAL | AB | RLD | 1996-12-17 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020702-004 | LIPITOR | EQ 80MG BASE | TABLET / ORAL | AB | RLD, RS | 2000-04-07 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020702-001 | LIPITOR | EQ 10MG BASE | TABLET / ORAL | AB | RLD | 1996-12-17 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020702-002 | LIPITOR | EQ 20MG BASE | TABLET / ORAL | AB | RLD | 1996-12-17 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020702-003 | LIPITOR | EQ 40MG BASE | TABLET / ORAL | AB | RLD | 1996-12-17 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020702-004 | LIPITOR | EQ 80MG BASE | TABLET / ORAL | AB | RLD, RS | 2000-04-07 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020702-001 | LIPITOR | EQ 10MG BASE | TABLET / ORAL | AB | RLD | 1996-12-17 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020702-002 | LIPITOR | EQ 20MG BASE | TABLET / ORAL | AB | RLD | 1996-12-17 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020702-003 | LIPITOR | EQ 40MG BASE | TABLET / ORAL | AB | RLD | 1996-12-17 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020702-004 | LIPITOR | EQ 80MG BASE | TABLET / ORAL | AB | RLD, RS | 2000-04-07 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020702-001 | LIPITOR | EQ 10MG BASE | TABLET / ORAL | AB | RLD | 1996-12-17 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020702-002 | LIPITOR | EQ 20MG BASE | TABLET / ORAL | AB | RLD | 1996-12-17 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020702-003 | LIPITOR | EQ 40MG BASE | TABLET / ORAL | AB | RLD | 1996-12-17 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020702-004 | LIPITOR | EQ 80MG BASE | TABLET / ORAL | AB | RLD, RS | 2000-04-07 | d8e5a09893c0… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N020702-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N020702-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N020702-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N020702-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N020702-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020702-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020702-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020702-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020702-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020702-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020702-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020702-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N020702-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020702-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020702-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020702-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020702-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020702-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020702-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020702-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020702-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020702-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020702-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020702-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020702-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020702-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020702-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020702-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020702-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020702-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020702-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020702-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020702-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020702-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020702-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020702-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020702-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020702-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020702-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020702-004 | AB | 1 | d8e5a09893c0… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N020702-001 | M-204 | 2020-06-23 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N020702-002 | M-204 | 2020-06-23 | 74a2ff9319b5… |
| 2020-12-22 03:56 UTC | 2020-12 | N020702-001 | M-204 | 2020-06-23 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N020702-002 | M-204 | 2020-06-23 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N020702-001 | M-204 | 2020-06-23 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N020702-002 | M-204 | 2020-06-23 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N020702-001 | M-204 | 2020-06-23 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N020702-002 | M-204 | 2020-06-23 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N020702-001 | M-204 | 2020-06-23 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N020702-002 | M-204 | 2020-06-23 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N020702-001 | M-204 | 2020-06-23 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N020702-002 | M-204 | 2020-06-23 | ea99ee380514… |
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 |
|---|---|---|---|---|---|---|
| Lipitor | ATORVASTATIN CALCIUM | Viatris Specialty LLC | a60cc18b-0631-4cf0-b021-9f52224ece65 | 2024-04-15 | Warnings, Adverse reactions | 020702 NDA020702 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0071-0155 | Lipitor | atorvastatin calcium | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0155 | Lipitor | atorvastatin calcium | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0155 | Lipitor | atorvastatin calcium | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0155 | Lipitor | atorvastatin calcium | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0155 | Lipitor | atorvastatin calcium | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0155 | Lipitor | atorvastatin calcium | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0155 | Lipitor | atorvastatin calcium | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0155 | Lipitor | atorvastatin calcium | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0155 | Lipitor | atorvastatin calcium | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0155 | Lipitor | atorvastatin calcium | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0155 | Lipitor | atorvastatin calcium | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0155 | Lipitor | atorvastatin calcium | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0155 | Lipitor | atorvastatin calcium | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0155 | Lipitor | atorvastatin calcium | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0156 | Lipitor | atorvastatin calcium | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0156 | Lipitor | atorvastatin calcium | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0156 | Lipitor | atorvastatin calcium | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0156 | Lipitor | atorvastatin calcium | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0156 | Lipitor | atorvastatin calcium | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0156 | Lipitor | atorvastatin calcium | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0156 | Lipitor | atorvastatin calcium | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0156 | Lipitor | atorvastatin calcium | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0156 | Lipitor | atorvastatin calcium | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0156 | Lipitor | atorvastatin calcium | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0156 | Lipitor | atorvastatin calcium | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0156 | Lipitor | atorvastatin calcium | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0156 | Lipitor | atorvastatin calcium | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0156 | Lipitor | atorvastatin calcium | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0157 | Lipitor | atorvastatin calcium | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0157 | Lipitor | atorvastatin calcium | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0157 | Lipitor | atorvastatin calcium | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0157 | Lipitor | atorvastatin calcium | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0157 | Lipitor | atorvastatin calcium | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0157 | Lipitor | atorvastatin calcium | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0157 | Lipitor | atorvastatin calcium | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0157 | Lipitor | atorvastatin calcium | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0157 | Lipitor | atorvastatin calcium | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0157 | Lipitor | atorvastatin calcium | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0157 | Lipitor | atorvastatin calcium | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0157 | Lipitor | atorvastatin calcium | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0157 | Lipitor | atorvastatin calcium | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0157 | Lipitor | atorvastatin calcium | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0158 | Lipitor | atorvastatin calcium | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0158 | Lipitor | atorvastatin calcium | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0158 | Lipitor | atorvastatin calcium | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0158 | Lipitor | atorvastatin calcium | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0158 | Lipitor | atorvastatin calcium | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0158 | Lipitor | atorvastatin calcium | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0158 | Lipitor | atorvastatin calcium | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0158 | Lipitor | atorvastatin calcium | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0158 | Lipitor | atorvastatin calcium | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0158 | Lipitor | atorvastatin calcium | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0158 | Lipitor | atorvastatin calcium | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0158 | Lipitor | atorvastatin calcium | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0158 | Lipitor | atorvastatin calcium | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0158 | Lipitor | atorvastatin calcium | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0179-0141 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | KAISER FOUNDATION HOSPITALS | NDA AUTHORIZED GENERIC | Current |
| 0179-0214 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | KAISER FOUNDATION HOSPITALS | NDA AUTHORIZED GENERIC | Current |
| 0179-0215 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | KAISER FOUNDATION HOSPITALS | NDA AUTHORIZED GENERIC | Current |
| 0179-0216 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | KAISER FOUNDATION HOSPITALS | NDA AUTHORIZED GENERIC | Current |
| 21695-255 | Lipitor | atorvastatin calcium | Rebel Distributors Corp | NDA | Current |
| 42254-019 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Rebel Distributors Corp | NDA AUTHORIZED GENERIC | Current |
| 42254-261 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Rebel Distributors Corp | NDA AUTHORIZED GENERIC | Current |
| 42254-267 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Rebel Distributors Corp | NDA AUTHORIZED GENERIC | Current |
| 42254-307 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Rebel Distributors Corp | NDA AUTHORIZED GENERIC | Current |
| 43353-120 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Aphena Pharma Solutions - Tennessee, LLC | NDA AUTHORIZED GENERIC | Current |
| 43353-120 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Aphena Pharma Solutions - Tennessee, LLC | NDA AUTHORIZED GENERIC | Current |
| 43353-826 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Aphena Pharma Solutions - Tennessee, LLC | NDA AUTHORIZED GENERIC | Current |
| 43353-826 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Aphena Pharma Solutions - Tennessee, LLC | NDA AUTHORIZED GENERIC | Current |
| 43353-827 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Aphena Pharma Solutions - Tennessee, LLC | NDA AUTHORIZED GENERIC | Current |
| 43353-827 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Aphena Pharma Solutions - Tennessee, LLC | NDA AUTHORIZED GENERIC | Current |
| 43353-892 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Aphena Pharma Solutions - Tennessee, LLC | NDA AUTHORIZED GENERIC | Current |
| 43353-892 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Aphena Pharma Solutions - Tennessee, LLC | NDA AUTHORIZED GENERIC | Current |
| 49299-1090 | LIPITOR | atorvastatin calcium | PHARMAKON, LLC | NDA | Current |
| 49299-1091 | LIPITOR | atorvastatin calcium | PHARMAKON, LLC | NDA | Current |
| 49299-1092 | LIPITOR | atorvastatin calcium | PHARMAKON, LLC | NDA | Current |
| 49299-1093 | LIPITOR | atorvastatin calcium | PHARMAKON, LLC | NDA | Current |
| 51655-880 | Atorvastatin Calcium | Atorvastatin Calcium | Northwind Pharmaceuticals | ANDA | Current |
| 53808-0951 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | State of Florida DOH Central Pharmacy | NDA AUTHORIZED GENERIC | Current |
| 55289-800 | Lipitor | atorvastatin calcium trihydrate | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 78046 | SUPPL | 2024-04-03 |
| 78041 | SUPPL | 2024-04-03 |
| 72893 | SUPPL | 2022-12-15 |
| 72831 | SUPPL | 2022-12-09 |
| 65260 | SUPPL | 2020-11-18 |
| 65234 | SUPPL | 2020-11-16 |
| 64723 | SUPPL | 2020-09-29 |
| 64699 | SUPPL | 2020-09-28 |
| 61105 | SUPPL | 2019-11-29 |
| 61091 | SUPPL | 2019-11-29 |
| 58348 | SUPPL | 2019-04-22 |
| 58330 | SUPPL | 2019-04-15 |
| 55225 | SUPPL | 2018-08-20 |
| 55168 | SUPPL | 2018-08-13 |
| 48846 | SUPPL | 2017-06-27 |
| 48845 | SUPPL | 2017-06-27 |
| 48840 | SUPPL | 2017-06-27 |
| 48839 | SUPPL | 2017-06-27 |
| 35179 | SUPPL | 2015-03-17 |
| 3135 | SUPPL | 2015-03-13 |
| 35178 | SUPPL | 2014-05-28 |
| 25577 | SUPPL | 2014-05-22 |
| 20856 | SUPPL | 2013-08-06 |
| 3134 | SUPPL | 2012-11-05 |
| 3133 | SUPPL | 2012-11-05 |
| 35177 | SUPPL | 2012-11-02 |
| 13249 | SUPPL | 2012-11-02 |
| 41591 | SUPPL | 2012-03-30 |
| 35176 | SUPPL | 2012-02-28 |
| 25576 | SUPPL | 2012-02-28 |
| 3132 | SUPPL | 2010-11-05 |
| 20841 | ORIG | 2010-03-16 |
| 35174 | SUPPL | 2009-06-22 |
| 35175 | SUPPL | 2009-04-03 |
| 25575 | SUPPL | 2009-04-01 |
| 41590 | SUPPL | 2008-08-01 |
| 20855 | SUPPL | 2008-08-01 |
| 41587 | SUPPL | 2008-07-31 |
| 20850 | SUPPL | 2008-02-19 |
| 20854 | SUPPL | 2007-12-06 |
| 20853 | SUPPL | 2007-12-06 |
| 20852 | SUPPL | 2007-12-06 |
| 41586 | SUPPL | 2007-11-19 |
| 41584 | SUPPL | 2007-11-19 |
| 41583 | SUPPL | 2007-11-19 |
| 20847 | SUPPL | 2007-11-19 |
| 20846 | SUPPL | 2007-11-19 |
| 20845 | SUPPL | 2007-11-19 |
| 25574 | SUPPL | 2007-10-04 |
| 41589 | SUPPL | 2007-09-26 |
| 41588 | SUPPL | 2007-09-26 |
| 35173 | SUPPL | 2007-09-26 |
| 41582 | SUPPL | 2007-07-06 |
| 20849 | SUPPL | 2007-07-06 |
| 25572 | SUPPL | 2007-03-07 |
| 13248 | SUPPL | 2007-03-07 |
| 25573 | SUPPL | 2007-01-25 |
| 35172 | SUPPL | 2007-01-18 |
| 35171 | SUPPL | 2006-08-09 |
| 3130 | SUPPL | 2006-08-09 |
| 23061 | SUPPL | 2006-06-28 |
| 3131 | SUPPL | 2006-06-27 |
| 3128 | SUPPL | 2005-10-20 |
| 3129 | SUPPL | 2005-10-14 |
| 35170 | SUPPL | 2005-09-30 |
| 25571 | SUPPL | 2004-08-02 |
| 13245 | SUPPL | 2004-06-08 |
| 3126 | SUPPL | 2004-06-08 |
| 43563 | SUPPL | 2004-05-27 |
| 25568 | SUPPL | 2004-05-26 |
| 13247 | SUPPL | 2003-10-10 |
| 25570 | SUPPL | 2003-10-09 |
| 3127 | SUPPL | 2003-06-08 |
| 13246 | SUPPL | 2003-05-29 |
| 25569 | SUPPL | 2002-10-18 |
| 13244 | SUPPL | 2002-10-18 |
| 35169 | SUPPL | 2002-04-22 |
| 3125 | SUPPL | 2002-04-22 |
| 20851 | SUPPL | 2002-04-10 |
| 25567 | SUPPL | 2001-06-15 |
| 13243 | SUPPL | 2001-06-15 |
| 41585 | SUPPL | 2001-02-26 |
| 25566 | SUPPL | 1999-12-02 |
| 20848 | SUPPL | 1998-12-14 |
| 20843 | SUPPL | 1998-11-12 |
| 41581 | SUPPL | 1998-10-23 |
| 25565 | SUPPL | 1998-07-10 |
| 20844 | SUPPL | 1998-07-10 |
| 3124 | SUPPL | 1998-07-10 |
| 20842 | SUPPL | 1997-11-28 |