Application 205519
- Type
- ANDA
- Sponsor
- SCIEGEN PHARMS 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 |
|---|---|---|---|---|---|---|---|
| A205519-001 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2016-05-19 | |
| A205519-002 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2016-05-19 | |
| A205519-003 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2016-05-19 | |
| A205519-004 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | AB | 2016-05-19 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A205519-001 | AB |
| A205519-002 | AB |
| A205519-003 | AB |
| A205519-004 | 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 | A205519-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2016-05-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A205519-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2016-05-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A205519-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2016-05-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A205519-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | AB | 2016-05-19 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A205519-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2016-05-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A205519-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2016-05-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A205519-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2016-05-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A205519-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | AB | 2016-05-19 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A205519-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2016-05-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A205519-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2016-05-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A205519-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2016-05-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A205519-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | AB | 2016-05-19 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205519-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2016-05-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205519-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2016-05-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205519-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2016-05-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205519-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | AB | 2016-05-19 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205519-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2016-05-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205519-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2016-05-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205519-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2016-05-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205519-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | AB | 2016-05-19 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205519-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2016-05-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205519-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2016-05-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205519-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2016-05-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205519-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | AB | 2016-05-19 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205519-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2016-05-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205519-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2016-05-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205519-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2016-05-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205519-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | AB | 2016-05-19 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205519-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2016-05-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205519-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2016-05-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205519-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2016-05-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205519-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | AB | 2016-05-19 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205519-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2016-05-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205519-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2016-05-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205519-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2016-05-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205519-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | AB | 2016-05-19 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205519-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2016-05-19 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205519-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2016-05-19 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205519-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2016-05-19 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205519-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | AB | 2016-05-19 | 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 | A205519-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A205519-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A205519-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A205519-004 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A205519-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A205519-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A205519-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A205519-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A205519-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A205519-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A205519-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A205519-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205519-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205519-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205519-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205519-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A205519-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A205519-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A205519-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A205519-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205519-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205519-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205519-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205519-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205519-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205519-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205519-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205519-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205519-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205519-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205519-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205519-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205519-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205519-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205519-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205519-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205519-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205519-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205519-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205519-004 | 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 | ScieGen Pharmaceuticals, Inc. | f2d8b5e9-6ff2-4efa-ab01-e13df29f7371 | 2026-08-07 | Warnings, Adverse reactions | 205519 ANDA205519 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Radha Pharmaceuticals, Inc. | 10e766cc-c3fd-4584-a0d7-652c516e828c | 2026-05-07 | Warnings, Adverse reactions | 205519 ANDA205519 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Bryant Ranch Prepack | d1b9e56b-1632-4450-b1ca-d8bcbba3fd7c | 2026-03-02 | Warnings, Adverse reactions | 205519 ANDA205519 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Bryant Ranch Prepack | e873d38c-4bda-4101-be98-85b1601d09f7 | 2026-02-18 | Warnings, Adverse reactions | 205519 ANDA205519 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Bryant Ranch Prepack | 1914264b-4c95-4066-91ca-b5c91d8b741e | 2026-02-18 | Warnings, Adverse reactions | 205519 ANDA205519 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Bryant Ranch Prepack | 5b9a5a36-7814-4d19-b146-01e819676ae2 | 2026-02-18 | Warnings, Adverse reactions | 205519 ANDA205519 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Coupler LLC | 47cd0227-90a5-cdf6-e063-6294a90af661 | 2026-01-07 | Warnings, Adverse reactions | 205519 ANDA205519 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Bryant Ranch Prepack | 44a39b5a-77b6-42e8-9319-df21d3678e02 | 2025-11-12 | Warnings, Adverse reactions | 205519 ANDA205519 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Bryant Ranch Prepack | 635addf1-2024-4675-8d3c-380dc4548fbd | 2025-11-11 | Warnings, Adverse reactions | 205519 ANDA205519 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Bryant Ranch Prepack | 66df5c0b-be89-4fc7-8f8d-c7689952c662 | 2025-11-11 | Warnings, Adverse reactions | 205519 ANDA205519 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Bryant Ranch Prepack | 271409d0-5500-4ed0-8730-5a93226a2191 | 2025-11-11 | Warnings, Adverse reactions | 205519 ANDA205519 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | NuCare Pharmaceuticals, Inc. | 51f23212-a10d-4cfa-e054-00144ff88e88 | 2025-02-04 | Warnings, Adverse reactions | 205519 ANDA205519 68071-3267 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Aphena Pharma Solutions - Tennessee, LLC | 3dbeae00-89ab-48a6-9e57-8048facb2294 | 2023-10-25 | Warnings, Adverse reactions | 205519 ANDA205519 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Proficient Rx LP | a34d3c72-ce91-47c7-86a1-f32caaed2c47 | 2022-10-01 | Warnings, Adverse reactions | 205519 ANDA205519 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Aphena Pharma Solutions - Tennessee, LLC | ed8e76a5-6b40-47fe-9018-25bfe690a4dd | 2018-10-18 | Warnings, Adverse reactions | 205519 ANDA205519 71610-163 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Cipla USA Inc., | 18fe5990-399d-416c-852f-e14974317b8b | 2018-03-13 | Warnings, Adverse reactions | 205519 ANDA205519 69097-911 69097-947 69097-898 69097-944 69097-945 69097-899 69097-897 69097-946 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Aphena Pharma Solutions - Tennessee, LLC | b16b3805-7e60-447c-b3df-7a9392b63c99 | 2018-02-20 | Warnings, Adverse reactions | 205519 ANDA205519 71610-036 |
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 |
|---|---|---|---|---|---|
| 68071-1886 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2788 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-3267 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3267 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-4179 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4308 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4308 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4308 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4797 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4797 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-7360 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7360 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 69097-897 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Cipla USA Inc., | ANDA | Current |
| 69097-898 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Cipla USA Inc., | ANDA | Current |
| 69097-899 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Cipla USA Inc., | ANDA | Current |
| 69097-911 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Cipla USA Inc., | ANDA | Current |
| 69097-944 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Cipla USA Inc., | ANDA | Current |
| 69097-945 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Cipla USA Inc., | ANDA | Current |
| 69097-946 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Cipla USA Inc., | ANDA | Current |
| 69097-947 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Cipla USA Inc., | ANDA | Current |
| 70518-0849 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | REMEDYREPACK INC. | ANDA | Current |
| 70518-0849 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | REMEDYREPACK INC. | ANDA | Current |
| 70518-1016 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | REMEDYREPACK INC. | ANDA | Current |
| 70518-1016 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | REMEDYREPACK INC. | ANDA | Current |
| 70518-1418 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | REMEDYREPACK INC. | ANDA | Current |
| 70518-1418 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | REMEDYREPACK INC. | ANDA | Current |
| 70518-1786 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | REMEDYREPACK INC. | ANDA | Current |
| 70518-1786 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | REMEDYREPACK INC. | ANDA | Current |
| 70518-2111 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | REMEDYREPACK INC. | ANDA | Current |
| 71335-0583 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Bryant Ranch Prepack | ANDA | Current |
| 71335-0583 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Bryant Ranch Prepack | ANDA | Current |
| 71335-0583 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Bryant Ranch Prepack | ANDA | Current |
| 71335-0767 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Bryant Ranch Prepack | ANDA | Current |
| 71335-0767 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Bryant Ranch Prepack | ANDA | Current |
| 71335-0767 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Bryant Ranch Prepack | ANDA | Current |
| 71335-0931 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Bryant Ranch Prepack | ANDA | Current |
| 71335-0931 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Bryant Ranch Prepack | ANDA | Current |
| 71335-0931 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Bryant Ranch Prepack | ANDA | Current |
| 71399-0510 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Akron Pharma Inc | ANDA | Current |
| 71399-0520 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Akron Pharma Inc | ANDA | Current |
| 71399-0540 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Akron Pharma Inc | ANDA | Current |
| 71399-0610 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Akron Pharma Inc | ANDA | Current |
| 71399-0620 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Akron Pharma Inc | ANDA | Current |
| 71399-0640 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Akron Pharma Inc | ANDA | Current |
| 71399-0680 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Akron Pharma Inc | ANDA | Current |
| 71610-036 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-094 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-163 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-168 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-168 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-169 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-169 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-170 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-170 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-180 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-180 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 76519-1084 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | H. J. Harkins Company Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 10457 | ORIG | 2016-05-24 |