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.
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 |
|---|---|---|---|---|---|
| 67296-1620 | Atorvastatin Calcium | Atorvastatin Calcium | RedPharm Drug, Inc. | ANDA | Current |
| 68071-1551 | Atorvastatin Calcium | Atorvastatin Calcium | NuCare pharmaceuticals,Inc. | ANDA | Current |
| 68071-1556 | Atorvastatin Calcium | Atorvastatin Calcium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-1556 | Atorvastatin Calcium | Atorvastatin Calcium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-1898 | Atorvastatin Calcium | Atorvastatin Calcium | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-1915 | Atorvastatin Calcium | Atorvastatin Calcium | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-1915 | Atorvastatin Calcium | Atorvastatin Calcium | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-2342 | Atorvastatin Calcium | Atorvastatin Calcium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-3047 | Atorvastatin Calcium | Atorvastatin Calcium | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3167 | Atorvastatin Calcium | Atorvastatin Calcium | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3399 | Atorvastatin Calcium | Atorvastatin Calcium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4136 | Atorvastatin Calcium | Atorvastatin Calcium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4136 | Atorvastatin Calcium | Atorvastatin Calcium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4150 | Atorvastatin Calcium | Atorvastatin Calcium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4150 | Atorvastatin Calcium | Atorvastatin Calcium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4171 | Atorvastatin Calcium | Atorvastatin Calcium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4171 | Atorvastatin Calcium | Atorvastatin Calcium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4171 | Atorvastatin Calcium | Atorvastatin Calcium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4220 | Atorvastatin Calcium | Atorvastatin Calcium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4220 | Atorvastatin Calcium | Atorvastatin Calcium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4220 | Atorvastatin Calcium | Atorvastatin Calcium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4220 | Atorvastatin Calcium | Atorvastatin Calcium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4279 | Atorvastatin Calcium | Atorvastatin Calcium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4287 | Atorvastatin Calcium | Atorvastatin Calcium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4287 | Atorvastatin Calcium | Atorvastatin Calcium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4287 | Atorvastatin Calcium | Atorvastatin Calcium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4654 | Atorvastatin Calcium | Atorvastatin Calcium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4654 | Atorvastatin Calcium | Atorvastatin Calcium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4861 | Atorvastatin Calcium | Atorvastatin Calcium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4861 | Atorvastatin Calcium | Atorvastatin Calcium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5237 | Atorvastatin Calcium | Atorvastatin Calcium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5237 | Atorvastatin Calcium | Atorvastatin Calcium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5246 | Atorvastatin Calcium | Atorvastatin Calcium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5246 | Atorvastatin Calcium | Atorvastatin Calcium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-6341 | Atorvastatin Calcium | Atorvastatin Calcium | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6341 | Atorvastatin Calcium | Atorvastatin Calcium | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6836 | Atorvastatin Calcium | Atorvastatin Calcium | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6836 | Atorvastatin Calcium | Atorvastatin Calcium | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6862 | Atorvastatin Calcium | Atorvastatin Calcium | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6862 | Atorvastatin Calcium | Atorvastatin Calcium | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6940 | Atorvastatin Calcium | Atorvastatin Calcium | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 70518-0494 | Atorvastatin Calcium | Atorvastatin Calcium | REMEDYREPACK INC. | ANDA | Current |
| 70518-0494 | Atorvastatin Calcium | Atorvastatin Calcium | REMEDYREPACK INC. | ANDA | Current |
| 70518-0878 | Atorvastatin Calcium | Atorvastatin Calcium | REMEDYREPACK INC. | ANDA | Current |
| 70518-0878 | Atorvastatin Calcium | Atorvastatin Calcium | REMEDYREPACK INC. | ANDA | Current |
| 70518-0878 | Atorvastatin Calcium | Atorvastatin Calcium | REMEDYREPACK INC. | ANDA | Current |
| 70518-0878 | Atorvastatin Calcium | Atorvastatin Calcium | REMEDYREPACK INC. | ANDA | Current |
| 70518-1131 | Atorvastatin Calcium | Atorvastatin Calcium | REMEDYREPACK INC. | ANDA | Current |
| 70518-1131 | Atorvastatin Calcium | Atorvastatin Calcium | REMEDYREPACK INC. | ANDA | Current |
| 70518-1147 | Atorvastatin Calcium | Atorvastatin Calcium | REMEDYREPACK INC. | ANDA | Current |
| 70518-1147 | Atorvastatin Calcium | Atorvastatin Calcium | REMEDYREPACK INC. | ANDA | Current |
| 70934-069 | Atorvastatin Calcium | Atorvastatin Calcium | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-069 | Atorvastatin Calcium | Atorvastatin Calcium | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-070 | Atorvastatin Calcium | Atorvastatin Calcium | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-070 | Atorvastatin Calcium | Atorvastatin Calcium | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 71335-0004 | Atorvastatin Calcium | Atorvastatin Calcium | Bryant Ranch Prepack | ANDA | Current |
| 71335-0004 | Atorvastatin Calcium | Atorvastatin Calcium | Bryant Ranch Prepack | ANDA | Current |
| 71335-0102 | Atorvastatin Calcium | Atorvastatin Calcium | Bryant Ranch Prepack | ANDA | Current |
| 71335-0102 | Atorvastatin Calcium | Atorvastatin Calcium | Bryant Ranch Prepack | ANDA | Current |
| 71335-0169 | Atorvastatin Calcium | Atorvastatin Calcium | Bryant Ranch Prepack | ANDA | Current |
| 71335-0169 | Atorvastatin Calcium | Atorvastatin Calcium | Bryant Ranch Prepack | ANDA | Current |
| 71335-1040 | Atorvastatin Calcium | Atorvastatin Calcium | Bryant Ranch Prepack | ANDA | Current |
| 71335-1040 | Atorvastatin Calcium | Atorvastatin Calcium | Bryant Ranch Prepack | ANDA | Current |
| 71335-1613 | Atorvastatin Calcium | Atorvastatin Calcium | Bryant Ranch Prepack | ANDA | Current |
| 71335-1613 | Atorvastatin Calcium | Atorvastatin Calcium | Bryant Ranch Prepack | ANDA | Current |
| 71610-116 | Atorvastatin Calcium | Atorvastatin Calcium | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 76519-1063 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | H.J Harkins Company Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 43254 | ORIG | 2015-03-09 |