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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A090548-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2012-05-29 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A090548-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2012-05-29 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A090548-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2012-05-29 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A090548-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | AB | 2012-05-29 | c2088c7a36db… | |
| 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… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A090548-001 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A090548-002 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A090548-003 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A090548-004 | AB | 1 | c2088c7a36db… |
| 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… |
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 | Bryant Ranch Prepack | 694a6a7f-9d46-46b0-9329-ad8c2bd5e403 | 2024-12-09 | Warnings, Adverse reactions | 090548 ANDA090548 71335-1051 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | A-S Medication Solutions | 25015637-c825-487c-ac33-c5ac46a4732f | 2024-10-08 | Warnings, Adverse reactions | 090548 ANDA090548 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | NCS HealthCare of KY, LLC dba Vangard Labs | 40e6b63f-0a20-404a-8915-2f698877a96b | 2024-08-19 | Warnings, Adverse reactions | 090548 ANDA090548 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | NCS HealthCare of KY, LLC dba Vangard Labs | 47709fe3-88d3-4d2e-b9db-a06dc1c2c7d4 | 2024-07-22 | Warnings, Adverse reactions | 090548 ANDA090548 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Bryant Ranch Prepack | 6c1e9bf3-ef52-4053-933d-5a5f7405e642 | 2024-07-17 | Warnings, Adverse reactions | 090548 ANDA090548 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | NuCare Pharmaceuticals, Inc. | 46df076d-4e98-6faa-e054-00144ff8d46c | 2024-07-16 | Warnings, Adverse reactions | 090548 ANDA090548 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | NuCare Pharmaceuticals,Inc. | e1935ab1-051b-7081-e053-2995a90a0901 | 2024-04-26 | Warnings, Adverse reactions | 090548 ANDA090548 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | A-S Medication Solutions | 7afe2137-b8b6-4506-818a-e5fadb2aee51 | 2023-11-26 | Warnings, Adverse reactions | 090548 ANDA090548 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | A-S Medication Solutions | 4ed5fd35-8212-4eb4-bf44-aeca788e4e4c | 2023-11-26 | Warnings, Adverse reactions | 090548 ANDA090548 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | A-S Medication Solutions | 1b8c55ef-160d-42df-95d1-c008f1182e3e | 2023-09-14 | Warnings, Adverse reactions | 090548 ANDA090548 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | A-S Medication Solutions | 107d7aed-582d-4296-99e9-ec63c41a594c | 2023-08-24 | Warnings, Adverse reactions | 090548 ANDA090548 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | A-S Medication Solutions | 77675dc3-868d-42a3-a179-80372a23e0c8 | 2023-07-21 | Warnings, Adverse reactions | 090548 ANDA090548 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | A-S Medication Solutions | 0ab0bcac-10a3-4178-9674-3730683a4183 | 2023-07-21 | Warnings, Adverse reactions | 090548 ANDA090548 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | A-S Medication Solutions | cbbdd932-a43b-4e88-af6d-cfe994c941b3 | 2023-05-19 | Warnings, Adverse reactions | 090548 ANDA090548 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Proficient Rx LP | 44f0df8b-6069-4941-87e9-2c57c8dfddfa | 2022-11-28 | Warnings, Adverse reactions | 090548 ANDA090548 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Proficient Rx LP | 957feff4-5005-4eea-bbe2-7232be65b0eb | 2022-10-01 | Warnings, Adverse reactions | 090548 ANDA090548 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Aphena Pharma Solutions - Tennessee, LLC | 2b7fbe2a-1f7a-4944-b589-87ca05af7481 | 2022-03-02 | Warnings, Adverse reactions | 090548 ANDA090548 71610-633 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Aphena Pharma Solutions - Tennessee, LLC | c0b4f1a2-0082-4150-8f2b-e7440252b675 | 2019-05-08 | Warnings, Adverse reactions | 090548 ANDA090548 71610-022 |
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 |