Application 076477
- Type
- ANDA
- Sponsor
- SUN PHARM INDS LTD
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 |
|---|---|---|---|---|---|---|---|
| A076477-001 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | 2011-11-30 | ||
| A076477-002 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | 2011-11-30 | ||
| A076477-003 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | 2011-11-30 | ||
| A076477-004 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | 2011-11-30 |
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 | A076477-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | 2011-11-30 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A076477-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | 2011-11-30 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A076477-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | 2011-11-30 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A076477-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | 2011-11-30 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076477-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | 2011-11-30 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076477-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | 2011-11-30 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076477-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | 2011-11-30 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076477-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | 2011-11-30 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076477-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | 2011-11-30 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076477-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | 2011-11-30 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076477-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | 2011-11-30 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076477-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | 2011-11-30 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076477-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | 2011-11-30 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076477-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | 2011-11-30 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076477-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | 2011-11-30 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076477-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | 2011-11-30 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076477-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | 2011-11-30 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076477-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | 2011-11-30 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076477-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | 2011-11-30 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076477-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | 2011-11-30 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076477-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2011-11-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076477-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2011-11-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076477-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2011-11-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076477-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | AB | 2011-11-30 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076477-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2011-11-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076477-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2011-11-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076477-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2011-11-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076477-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | AB | 2011-11-30 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076477-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2011-11-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076477-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2011-11-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076477-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2011-11-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076477-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | AB | 2011-11-30 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076477-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2011-11-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076477-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2011-11-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076477-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2011-11-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076477-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | AB | 2011-11-30 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076477-001 | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2011-11-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076477-002 | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2011-11-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076477-003 | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2011-11-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076477-004 | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET / ORAL | AB | 2011-11-30 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076477-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076477-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076477-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076477-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076477-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076477-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076477-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076477-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076477-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076477-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076477-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076477-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076477-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076477-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076477-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076477-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076477-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076477-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076477-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076477-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076477-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076477-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076477-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076477-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A076477-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A076477-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A076477-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A076477-004 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076477-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076477-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076477-003 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076477-004 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076477-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076477-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076477-003 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076477-004 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076477-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076477-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076477-003 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076477-004 | AB | 1 | 1e350fbaab3a… |
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 | 2e583569-499d-4f20-87ca-84e7d9868d22 | 2026-07-14 | Warnings, Adverse reactions | 076477 ANDA076477 71335-1011 |
| Atorvastatin Calcium | ATORVASTATIN CALCIUM | Sun Pharmaceutical Industries Inc. | 595ab888-6b55-4642-a32f-e8521821ed81 | 2026-06-04 | Warnings, Adverse reactions | 076477 ANDA076477 |
| Atorvastatin Calcium | ATORVASTATIN CALCIUM | NuCare Pharmaceuticals, Inc. | 49dcc58a-9f23-045d-e063-6394a90abda6 | 2026-02-02 | Warnings, Adverse reactions | 076477 ANDA076477 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | DIRECT RX | c3b70f79-45a3-0869-e053-2a95a90a3cdb | 2025-01-20 | Warnings, Adverse reactions | 076477 ANDA076477 72189-226 |
| Atorvastatin Calcium | ATORVASTATIN CALCIUM | Bryant Ranch Prepack | f7af3b3a-b73e-41ee-80e3-2be036672bb7 | 2024-08-22 | Warnings, Adverse reactions | 076477 ANDA076477 71335-1710 |
| Atorvastatin Calcium | ATORVASTATIN CALCIUM | NuCare Pharmaceuticals,Inc. | b1a840cf-47aa-b931-e053-2a95a90a1047 | 2024-07-17 | Warnings, Adverse reactions | 076477 ANDA076477 |
| Atorvastatin Calcium | ATORVASTATIN CALCIUM | Bryant Ranch Prepack | bbb1a527-3b4d-4fd4-9e38-b231ad5d6d8f | 2024-05-30 | Warnings, Adverse reactions | 076477 ANDA076477 71335-1010 |
| Atorvastatin Calcium | ATORVASTATIN CALCIUM | Proficient Rx LP | d77e155c-403d-449e-bafd-11c9bd4974dd | 2020-01-01 | Warnings, Adverse reactions | 076477 ANDA076477 |
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 |
|---|---|---|---|---|---|
| 71335-1010 | Atorvastatin Calcium | Atorvastatin Calcium | Bryant Ranch Prepack | ANDA | Current |
| 71335-1010 | Atorvastatin Calcium | Atorvastatin Calcium | Bryant Ranch Prepack | ANDA | Current |
| 71335-1010 | Atorvastatin Calcium | Atorvastatin Calcium | Bryant Ranch Prepack | ANDA | Current |
| 71335-1010 | Atorvastatin Calcium | Atorvastatin Calcium | Bryant Ranch Prepack | ANDA | Current |
| 71335-1010 | Atorvastatin Calcium | Atorvastatin Calcium | Bryant Ranch Prepack | ANDA | Current |
| 71335-1011 | Atorvastatin Calcium | Atorvastatin Calcium | Bryant Ranch Prepack | ANDA | Current |
| 71335-1011 | Atorvastatin Calcium | Atorvastatin Calcium | Bryant Ranch Prepack | ANDA | Current |
| 71335-1011 | Atorvastatin Calcium | Atorvastatin Calcium | Bryant Ranch Prepack | ANDA | Current |
| 71335-1011 | Atorvastatin Calcium | Atorvastatin Calcium | Bryant Ranch Prepack | ANDA | Current |
| 71335-1011 | Atorvastatin Calcium | Atorvastatin Calcium | Bryant Ranch Prepack | ANDA | Current |
| 71335-1322 | Atorvastatin Calcium | Atorvastatin Calcium | Bryant Ranch Prepack | ANDA | Current |
| 71335-1322 | Atorvastatin Calcium | Atorvastatin Calcium | Bryant Ranch Prepack | ANDA | Current |
| 71335-1641 | Atorvastatin Calcium | Atorvastatin Calcium | Bryant Ranch Prepack | ANDA | Current |
| 71335-1641 | ATORVASTATIN CALCIUM | Atorvastatin Calcium | Bryant Ranch Prepack | ANDA | Current |
| 71335-1710 | Atorvastatin Calcium | Atorvastatin Calcium | Bryant Ranch Prepack | ANDA | Current |
| 71335-1710 | Atorvastatin Calcium | Atorvastatin Calcium | Bryant Ranch Prepack | ANDA | Current |
| 71335-1710 | Atorvastatin Calcium | Atorvastatin Calcium | Bryant Ranch Prepack | ANDA | Current |
| 72189-226 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | DIRECT RX | ANDA | Current |
| 72189-226 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | DIRECT RX | ANDA | Current |
| 72189-226 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | DIRECT RX | ANDA | Current |