Application 090548
- Type
- ANDA
- Sponsor
- APOTEX INC
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 |
|---|---|---|---|---|---|---|---|
| A090548-001 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2012-05-29 | |
| A090548-002 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2012-05-29 | |
| A090548-003 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2012-05-29 | |
| A090548-004 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | AB | 2012-05-29 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A090548-001 | AB |
| A090548-002 | AB |
| A090548-003 | AB |
| A090548-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A090548-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2012-05-29 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A090548-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2012-05-29 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A090548-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2012-05-29 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A090548-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | AB | 2012-05-29 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A090548-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2012-05-29 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A090548-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2012-05-29 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A090548-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2012-05-29 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A090548-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | AB | 2012-05-29 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090548-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2012-05-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090548-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2012-05-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090548-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2012-05-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090548-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | AB | 2012-05-29 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090548-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2012-05-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090548-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2012-05-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090548-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2012-05-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090548-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | AB | 2012-05-29 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090548-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2012-05-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090548-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2012-05-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090548-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2012-05-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090548-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | AB | 2012-05-29 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090548-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2012-05-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090548-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2012-05-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090548-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2012-05-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090548-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | AB | 2012-05-29 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090548-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2012-05-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090548-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2012-05-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090548-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2012-05-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090548-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | AB | 2012-05-29 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090548-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2012-05-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090548-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2012-05-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090548-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2012-05-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090548-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | AB | 2012-05-29 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090548-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2012-05-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090548-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2012-05-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090548-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2012-05-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090548-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | AB | 2012-05-29 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090548-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2012-05-29 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090548-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2012-05-29 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090548-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2012-05-29 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090548-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | AB | 2012-05-29 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A090548-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A090548-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A090548-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A090548-004 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A090548-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A090548-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A090548-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A090548-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A090548-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090548-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090548-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090548-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090548-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090548-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090548-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090548-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A090548-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090548-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090548-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090548-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090548-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090548-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090548-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090548-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090548-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090548-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090548-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090548-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090548-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090548-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090548-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090548-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090548-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090548-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090548-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090548-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090548-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090548-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090548-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090548-004 | AB | 1 | 5bbf6a4d5a75… |
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 | Quallent | f00a83aa-3f1d-566d-b9bb-f396f22a27cb | 2026-09-08 | Warnings, Adverse reactions | 090548 ANDA090548 82009-001 82009-003 82009-004 82009-002 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Apotex Corp. | d9adb9e4-c495-9530-e5e3-7e3b01d53e4c | 2026-09-08 | Warnings, Adverse reactions | 090548 ANDA090548 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Major Pharmaceuticals | 634ec8e3-6d83-4cb2-90a3-fc9c973b06bf | 2026-08-21 | Warnings, Adverse reactions | 090548 ANDA090548 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | REMEDYREPACK INC. | d57720ab-9f83-4da9-a57f-0d55e00a605c | 2026-08-17 | Warnings, Adverse reactions | 090548 ANDA090548 70518-0224 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Major Pharmaceuticals | e74278b6-31fc-48d4-97b7-ba500e9e15fb | 2026-07-27 | Warnings, Adverse reactions | 090548 ANDA090548 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | NORTHSTAR RX LLC | 52d8508b-aa98-cd89-5991-e2b5f982b6c6 | 2026-07-08 | Warnings, Adverse reactions | 090548 ANDA090548 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Unit Dose Solutions, Inc. | 53c06fa9-ec26-5fa6-e063-6294a90a337f | 2026-06-08 | Warnings, Adverse reactions | 090548 ANDA090548 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Cardinal Health 107, LLC | 75ea68e0-12e2-4e27-876f-f24f6e33a0b7 | 2026-05-29 | Warnings, Adverse reactions | 090548 ANDA090548 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Cardinal Health 107, LLC | ed57fc60-ecb2-419e-b09f-3c518dcf3d04 | 2026-05-15 | Warnings, Adverse reactions | 090548 ANDA090548 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Cardinal Health 107, LLC | 1272aada-9a5b-4397-bb65-9398927aa325 | 2026-04-22 | Warnings, Adverse reactions | 090548 ANDA090548 |
| Atorvastatin Calcium | ATORVASTATIN CALCIUM | Cardinal Health 107, LLC | ed0d5c17-0481-4d6b-8051-8d6e47f49ce5 | 2026-04-10 | Warnings, Adverse reactions | 090548 ANDA090548 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | AvPAK | b687ba81-cb24-bbdf-5dd9-ab0e53dd480b | 2026-03-24 | Warnings, Adverse reactions | 090548 ANDA090548 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | NuCare Pharmaceuticals, Inc. | 4a2bad30-e7cf-c48a-e063-6294a90a5f47 | 2026-03-20 | Warnings, Adverse reactions | 090548 ANDA090548 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Northwind Health Company, LLC | f32c8a4f-dee9-86a0-e053-2995a90a3388 | 2026-01-01 | Warnings, Adverse reactions | 090548 ANDA090548 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Northwind Health Company, LLC | f76b9e48-3ef7-e15a-e053-6394a90aed58 | 2026-01-01 | Warnings, Adverse reactions | 090548 ANDA090548 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Northwind Health Company, LLC | 0e10adb3-8d3a-412f-ae56-d9b9bed4641f | 2026-01-01 | Warnings, Adverse reactions | 090548 ANDA090548 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Northwind Health Company, LLC | 0c5823ce-ed5c-356c-e063-6394a90aa15d | 2025-12-26 | Warnings, Adverse reactions | 090548 ANDA090548 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | QPharma, Inc. | f7cc5704-2131-4bcb-9ff0-33a79a8167bd | 2025-12-05 | Warnings, Adverse reactions | 090548 ANDA090548 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | QPharma, Inc. | d8a72abf-1d43-47e1-88e8-c3c5cc4ba163 | 2025-12-03 | Warnings, Adverse reactions | 090548 ANDA090548 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | NCS HealthCare of KY, LLC dba Vangard Labs | 7353f9ef-6f79-4522-886a-7a8ae4eb867e | 2025-11-11 | Warnings, Adverse reactions | 090548 ANDA090548 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 68788-7618 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7618 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7874 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Preferred Pharmaceuticals Inc | ANDA | Current |
| 68788-7874 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Preferred Pharmaceuticals Inc | ANDA | Current |
| 68788-8991 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-9556 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9681 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9683 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 70518-0186 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | REMEDYREPACK INC. | ANDA | Current |
| 70518-0186 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | REMEDYREPACK INC. | ANDA | Current |
| 70518-0186 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | REMEDYREPACK INC. | ANDA | Current |
| 70518-0186 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | REMEDYREPACK INC. | ANDA | Current |
| 70518-0224 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | REMEDYREPACK INC. | ANDA | Current |
| 70518-0224 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | REMEDYREPACK INC. | ANDA | Current |
| 70518-0224 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | REMEDYREPACK INC. | ANDA | Current |
| 70518-1322 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | REMEDYREPACK INC. | ANDA | Current |
| 70518-1322 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | REMEDYREPACK INC. | ANDA | Current |
| 70518-1322 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | REMEDYREPACK INC. | ANDA | Current |
| 70518-1322 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | REMEDYREPACK INC. | ANDA | Current |
| 70518-1322 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | REMEDYREPACK INC. | ANDA | Current |
| 70518-1322 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | REMEDYREPACK INC. | ANDA | Current |
| 70518-1322 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | REMEDYREPACK INC. | ANDA | Current |
| 70518-1514 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | REMEDYREPACK INC. | ANDA | Current |
| 70518-1514 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | REMEDYREPACK INC. | ANDA | Current |
| 70518-1514 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | REMEDYREPACK INC. | ANDA | Current |
| 70518-1514 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | REMEDYREPACK INC. | ANDA | Current |
| 70518-1514 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | REMEDYREPACK INC. | ANDA | Current |
| 70786-2578 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Unit Dose Services | ANDA | Current |
| 70786-2579 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Unit Dose Services | ANDA | Current |
| 70786-2580 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Unit Dose Services | ANDA | Current |
| 70786-2671 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Unit Dose Services | ANDA | Current |
| 70882-109 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Cambridge Therapeutics Technologies, LLC | ANDA | Current |
| 70882-119 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Cambridge Therapeutics Technologies, LLC | ANDA | Current |
| 70882-120 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Cambridge Therapeutics Technologies, LLC | ANDA | Current |
| 70934-091 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-091 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-250 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-250 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-989 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 71335-0295 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Bryant Ranch Prepack | ANDA | Current |
| 71335-0295 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Bryant Ranch Prepack | ANDA | Current |
| 71335-1051 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Bryant Ranch Prepack | ANDA | Current |
| 71335-1051 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Bryant Ranch Prepack | ANDA | Current |
| 71335-1051 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Bryant Ranch Prepack | ANDA | Current |
| 71335-1051 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Bryant Ranch Prepack | ANDA | Current |
| 71335-1051 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Bryant Ranch Prepack | ANDA | Current |
| 71610-022 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-022 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-633 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 82009-001 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Quallent | ANDA | Current |
| 82009-001 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Quallent | ANDA | Current |
| 82009-001 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Quallent | ANDA | Current |
| 82009-002 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Quallent | ANDA | Current |
| 82009-002 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Quallent | ANDA | Current |
| 82009-002 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Quallent | ANDA | Current |
| 82009-003 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Quallent | ANDA | Current |
| 82009-003 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Quallent | ANDA | Current |
| 82009-003 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Quallent | ANDA | Current |
| 82009-004 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Quallent | ANDA | Current |
| 82009-004 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Quallent | ANDA | Current |
| 82009-004 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Quallent | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 22711 | ORIG | 2015-03-09 |