Application 091624
- Type
- ANDA
- Sponsor
- LANNETT CO 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 |
|---|---|---|---|---|---|---|---|
| A091624-001 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2013-04-05 | |
| A091624-002 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2013-04-05 | |
| A091624-003 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2013-04-05 | |
| A091624-004 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | AB | 2013-04-05 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A091624-001 | AB |
| A091624-002 | AB |
| A091624-003 | AB |
| A091624-004 | 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 | A091624-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2013-04-05 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A091624-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2013-04-05 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A091624-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2013-04-05 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A091624-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | AB | 2013-04-05 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A091624-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2013-04-05 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A091624-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2013-04-05 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A091624-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2013-04-05 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A091624-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | AB | 2013-04-05 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091624-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2013-04-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091624-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2013-04-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091624-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2013-04-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091624-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | AB | 2013-04-05 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091624-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2013-04-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091624-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2013-04-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091624-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2013-04-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091624-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | AB | 2013-04-05 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091624-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2013-04-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091624-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2013-04-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091624-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2013-04-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091624-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | AB | 2013-04-05 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091624-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2013-04-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091624-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2013-04-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091624-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2013-04-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091624-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | AB | 2013-04-05 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091624-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2013-04-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091624-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2013-04-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091624-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2013-04-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091624-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | AB | 2013-04-05 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091624-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2013-04-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091624-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2013-04-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091624-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2013-04-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091624-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | AB | 2013-04-05 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091624-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2013-04-05 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091624-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2013-04-05 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091624-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2013-04-05 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091624-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | AB | 2013-04-05 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091624-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2013-04-05 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091624-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2013-04-05 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091624-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2013-04-05 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091624-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | AB | 2013-04-05 | 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 | A091624-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A091624-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A091624-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A091624-004 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A091624-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A091624-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A091624-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A091624-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A091624-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091624-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091624-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091624-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091624-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091624-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091624-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091624-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A091624-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091624-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091624-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091624-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091624-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091624-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091624-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091624-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091624-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091624-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091624-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091624-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091624-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091624-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091624-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091624-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091624-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091624-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091624-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091624-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091624-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091624-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091624-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091624-004 | 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 | Dr. Reddy's Laboratories Limited | 901550e6-22be-68c9-eb86-f85a9c9dd998 | 2021-06-20 | Warnings, Adverse reactions | Atorvastatin Calcium ATORVASTATIN CALCIUM |
| Atorvastatin Calcium | ATORVASTATIN CALCIUM | Dr. Reddy's Laboratories Limited | 6ccdb6f3-22c7-5b48-46bc-ce4a4c65eb4d | 2020-11-30 | Warnings, Adverse reactions | Atorvastatin Calcium ATORVASTATIN CALCIUM |
| Atorvastatin Calcium | ATORVASTATIN CALCIUM | Proficient Rx LP | d77e155c-403d-449e-bafd-11c9bd4974dd | 2020-01-01 | Warnings, Adverse reactions | Atorvastatin Calcium ATORVASTATIN CALCIUM |
| Atorvastatin Calcium | ATORVASTATIN CALCIUM | Proficient Rx LP | bd56a76b-5570-46a7-9399-fc110d913bf9 | 2019-10-01 | Warnings, Adverse reactions | Atorvastatin Calcium ATORVASTATIN CALCIUM |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Aphena Pharma Solutions - Tennessee, LLC | c0b4f1a2-0082-4150-8f2b-e7440252b675 | 2019-05-08 | Warnings, Adverse reactions | ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Aphena Pharma Solutions - Tennessee, LLC | ed8e76a5-6b40-47fe-9018-25bfe690a4dd | 2018-10-18 | Warnings, Adverse reactions | ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Cipla USA Inc., | 18fe5990-399d-416c-852f-e14974317b8b | 2018-03-13 | Warnings, Adverse reactions | ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Aphena Pharma Solutions - Tennessee, LLC | b16b3805-7e60-447c-b3df-7a9392b63c99 | 2018-02-20 | Warnings, Adverse reactions | ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM |
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 |
|---|---|---|---|---|---|
| 43063-487 | Atorvastatin Calcium | Atorvastatin Calcium | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-487 | Atorvastatin Calcium | Atorvastatin Calcium | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-487 | Atorvastatin Calcium | Atorvastatin Calcium | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-487 | Atorvastatin Calcium | Atorvastatin Calcium | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-487 | Atorvastatin Calcium | Atorvastatin Calcium | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43353-280 | Atorvastatin Calcium | Atorvastatin Calcium | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-983 | Atorvastatin Calcium | Atorvastatin Calcium | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 45865-726 | Atorvastatin Calcium | Atorvastatin Calcium | medsource pharmaceuticals | ANDA | Current |
| 45865-743 | Atorvastatin Calcium | Atorvastatin Calcium | medsource pharmaceuticals | ANDA | Current |
| 50090-1255 | Atorvastatin Calcium | Atorvastatin Calcium | A-S Medication Solutions | ANDA | Current |
| 50090-1255 | Atorvastatin Calcium | Atorvastatin Calcium | A-S Medication Solutions | ANDA | Current |
| 50090-1258 | Atorvastatin Calcium | Atorvastatin Calcium | A-S Medication Solutions | ANDA | Current |
| 50090-1258 | Atorvastatin Calcium | Atorvastatin Calcium | A-S Medication Solutions | ANDA | Current |
| 50090-1261 | Atorvastatin Calcium | Atorvastatin Calcium | A-S Medication Solutions | ANDA | Current |
| 50090-1265 | Atorvastatin Calcium | Atorvastatin Calcium | A-S Medication Solutions | ANDA | Current |
| 50090-5069 | Atorvastatin Calcium | Atorvastatin Calcium | A-S Medication Solutions | ANDA | Current |
| 50090-5069 | Atorvastatin Calcium | Atorvastatin Calcium | A-S Medication Solutions | ANDA | Current |
| 51655-614 | Atorvastatin Calcium | Atorvastatin Calcium | Northwind Pharmaceuticals | ANDA | Current |
| 51655-650 | atorvastatin calcium | atorvastatin calcium | Northwind Pharmaceuticals, LLC | ANDA | Current |
| 51655-921 | Atorvastatin Calcium | Atorvastatin Calcium | Northwind Pharmaceuticals | ANDA | Current |
| 53002-1335 | Atorvastatin Calcium | Atorvastatin Calcium | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-1335 | Atorvastatin Calcium | Atorvastatin Calcium | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-1439 | Atorvastatin Calcium | Atorvastatin Calcium | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-1439 | Atorvastatin Calcium | Atorvastatin Calcium | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-1440 | Atorvastatin Calcium | Atorvastatin Calcium | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-1440 | Atorvastatin Calcium | Atorvastatin Calcium | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53217-209 | Atorvastatin Calcium | Atorvastatin Calcium | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 55700-659 | Atorvastatin Calcium | Atorvastatin Calcium | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-659 | Atorvastatin Calcium | Atorvastatin Calcium | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 60760-903 | Atorvastatin Calcium | Atorvastatin Calcium | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-903 | Atorvastatin Calcium | Atorvastatin Calcium | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-904 | Atorvastatin Calcium | Atorvastatin Calcium | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-905 | Atorvastatin Calcium | Atorvastatin Calcium | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-905 | Atorvastatin Calcium | Atorvastatin Calcium | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-905 | Atorvastatin Calcium | Atorvastatin Calcium | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-905 | Atorvastatin Calcium | Atorvastatin Calcium | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-905 | Atorvastatin Calcium | Atorvastatin Calcium | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 61919-632 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | DIRECT RX | ANDA | Current |
| 61919-632 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | DIRECT RX | ANDA | Current |
| 61919-632 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | DIRECT RX | ANDA | Current |
| 61919-956 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | DIRECT RX | ANDA | Current |
| 61919-956 | Atorvastatin Calcium | Atorvastatin Calcium | Direct_Rx | ANDA | Current |
| 61919-956 | Atorvastatin Calcium | Atorvastatin Calcium | Direct_Rx | ANDA | Current |
| 61919-956 | Atorvastatin Calcium | Atorvastatin Calcium | Direct_Rx | ANDA | Current |
| 61919-956 | Atorvastatin Calcium | Atorvastatin Calcium | Direct_Rx | ANDA | Current |
| 62175-890 | Atorvastatin Calcium | Atorvastatin Calcium | Lannett Company, Inc. | ANDA | Current |
| 62175-890 | Atorvastatin Calcium | Atorvastatin Calcium | Lannett Company, Inc. | ANDA | Current |
| 62175-890 | Atorvastatin Calcium | Atorvastatin Calcium | Lannett Company, Inc. | ANDA | Current |
| 62175-890 | Atorvastatin Calcium | Atorvastatin Calcium | Lannett Company, Inc.. | ANDA | Current |
| 62175-890 | Atorvastatin Calcium | Atorvastatin Calcium | Lannett Company, Inc. | ANDA | Current |
| 62175-890 | Atorvastatin Calcium | Atorvastatin Calcium | Lannett Company, Inc. | ANDA | Current |
| 62175-891 | Atorvastatin Calcium | Atorvastatin Calcium | Lannett Company, Inc. | ANDA | Current |
| 62175-891 | Atorvastatin Calcium | Atorvastatin Calcium | Lannett Company, Inc. | ANDA | Current |
| 62175-891 | Atorvastatin Calcium | Atorvastatin Calcium | Lannett Company, Inc. | ANDA | Current |
| 62175-891 | Atorvastatin Calcium | Atorvastatin Calcium | Lannett Company, Inc.. | ANDA | Current |
| 62175-891 | Atorvastatin Calcium | Atorvastatin Calcium | Lannett Company, Inc. | ANDA | Current |
| 62175-891 | Atorvastatin Calcium | Atorvastatin Calcium | Lannett Company, Inc. | ANDA | Current |
| 62175-892 | Atorvastatin Calcium | Atorvastatin Calcium | Lannett Company, Inc. | ANDA | Current |
| 62175-892 | Atorvastatin Calcium | Atorvastatin Calcium | Lannett Company, Inc. | ANDA | Current |
| 62175-892 | Atorvastatin Calcium | Atorvastatin Calcium | Lannett Company, Inc. | ANDA | Current |
| 62175-892 | Atorvastatin Calcium | Atorvastatin Calcium | Lannett Company, Inc.. | ANDA | Current |
| 62175-892 | Atorvastatin Calcium | Atorvastatin Calcium | Lannett Company, Inc. | ANDA | Current |
| 62175-892 | Atorvastatin Calcium | Atorvastatin Calcium | Lannett Company, Inc. | ANDA | Current |
| 62175-897 | Atorvastatin Calcium | Atorvastatin Calcium | Lannett Company, Inc. | ANDA | Current |
| 62175-897 | Atorvastatin Calcium | Atorvastatin Calcium | Lannett Company, Inc. | ANDA | Current |
| 62175-897 | Atorvastatin Calcium | Atorvastatin Calcium | Lannett Company, Inc. | ANDA | Current |
| 62175-897 | Atorvastatin Calcium | Atorvastatin Calcium | Lannett Company, Inc.. | ANDA | Current |
| 62175-897 | Atorvastatin Calcium | Atorvastatin Calcium | Lannett Company, Inc. | ANDA | Current |
| 62175-897 | Atorvastatin Calcium | Atorvastatin Calcium | Lannett Company, Inc. | ANDA | Current |
| 63187-336 | Atorvastatin Calcium | Atorvastatin Calcium | Proficient Rx LP | ANDA | Current |
| 63187-336 | Atorvastatin Calcium | Atorvastatin Calcium | Proficient Rx LP | ANDA | Current |
| 63187-336 | Atorvastatin Calcium | Atorvastatin Calcium | Proficient Rx LP | ANDA | Current |
| 63187-346 | Atorvastatin Calcium | Atorvastatin Calcium | Proficient Rx LP | ANDA | Current |
| 63187-346 | Atorvastatin Calcium | Atorvastatin Calcium | Proficient Rx LP | ANDA | Current |
| 63187-346 | Atorvastatin Calcium | Atorvastatin Calcium | Proficient Rx LP | ANDA | Current |
| 63629-8031 | Atorvastatin Calcium | Atorvastatin Calcium | Bryant Ranch Prepack | ANDA | Current |
| 63629-8031 | Atorvastatin Calcium | Atorvastatin Calcium | Bryant Ranch Prepack | ANDA | Current |
| 63629-8033 | Atorvastatin Calcium | Atorvastatin Calcium | Bryant Ranch Prepack | ANDA | Current |
| 63629-8033 | Atorvastatin Calcium | Atorvastatin Calcium | Bryant Ranch Prepack | ANDA | Current |
| 67296-1620 | Atorvastatin Calcium | Atorvastatin Calcium | RedPharm Drug, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 43254 | ORIG | 2015-03-09 |