Application 208647
- Type
- NDA
- Sponsor
- SUN PHARMA GLOBAL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | EZALLOR | ROSUVASTATIN CALCIUM | CAPSULE;ORAL | EQ 5MG BASE | Yes | No |
| 002 | EZALLOR | ROSUVASTATIN CALCIUM | CAPSULE;ORAL | EQ 10MG BASE | Yes | No |
| 003 | EZALLOR | ROSUVASTATIN CALCIUM | CAPSULE;ORAL | EQ 20MG BASE | Yes | No |
| 004 | EZALLOR | ROSUVASTATIN CALCIUM | CAPSULE;ORAL | EQ 40MG BASE | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N208647-001 | EZALLOR SPRINKLE | ROSUVASTATIN CALCIUM | EQ 5MG BASE | CAPSULE / ORAL | RLD | 2018-12-18 | |
| N208647-002 | EZALLOR SPRINKLE | ROSUVASTATIN CALCIUM | EQ 10MG BASE | CAPSULE / ORAL | RLD | 2018-12-18 | |
| N208647-003 | EZALLOR SPRINKLE | ROSUVASTATIN CALCIUM | EQ 20MG BASE | CAPSULE / ORAL | RLD | 2018-12-18 | |
| N208647-004 | EZALLOR SPRINKLE | ROSUVASTATIN CALCIUM | EQ 40MG BASE | CAPSULE / ORAL | RLD | 2018-12-18 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N208647-001 | 10413543 | 2036-02-12 | Drug product | 2019-10-09 | |
| N208647-002 | 10413543 | 2036-02-12 | Drug product | 2019-10-09 | |
| N208647-003 | 10413543 | 2036-02-12 | Drug product | 2019-10-09 | |
| N208647-004 | 10413543 | 2036-02-12 | Drug product | 2019-10-09 |
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 | N208647-001 | EZALLOR SPRINKLE | EQ 5MG BASE | CAPSULE / ORAL | RLD | 2018-12-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N208647-002 | EZALLOR SPRINKLE | EQ 10MG BASE | CAPSULE / ORAL | RLD | 2018-12-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N208647-003 | EZALLOR SPRINKLE | EQ 20MG BASE | CAPSULE / ORAL | RLD | 2018-12-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N208647-004 | EZALLOR SPRINKLE | EQ 40MG BASE | CAPSULE / ORAL | RLD | 2018-12-18 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N208647-001 | EZALLOR SPRINKLE | EQ 5MG BASE | CAPSULE / ORAL | RLD | 2018-12-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N208647-002 | EZALLOR SPRINKLE | EQ 10MG BASE | CAPSULE / ORAL | RLD | 2018-12-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N208647-003 | EZALLOR SPRINKLE | EQ 20MG BASE | CAPSULE / ORAL | RLD | 2018-12-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N208647-004 | EZALLOR SPRINKLE | EQ 40MG BASE | CAPSULE / ORAL | RLD | 2018-12-18 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208647-001 | EZALLOR SPRINKLE | EQ 5MG BASE | CAPSULE / ORAL | RLD | 2018-12-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208647-002 | EZALLOR SPRINKLE | EQ 10MG BASE | CAPSULE / ORAL | RLD | 2018-12-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208647-003 | EZALLOR SPRINKLE | EQ 20MG BASE | CAPSULE / ORAL | RLD | 2018-12-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208647-004 | EZALLOR SPRINKLE | EQ 40MG BASE | CAPSULE / ORAL | RLD | 2018-12-18 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208647-001 | EZALLOR SPRINKLE | EQ 5MG BASE | CAPSULE / ORAL | RLD | 2018-12-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208647-002 | EZALLOR SPRINKLE | EQ 10MG BASE | CAPSULE / ORAL | RLD | 2018-12-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208647-003 | EZALLOR SPRINKLE | EQ 20MG BASE | CAPSULE / ORAL | RLD | 2018-12-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208647-004 | EZALLOR SPRINKLE | EQ 40MG BASE | CAPSULE / ORAL | RLD | 2018-12-18 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208647-001 | EZALLOR SPRINKLE | EQ 5MG BASE | CAPSULE / ORAL | RLD | 2018-12-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208647-002 | EZALLOR SPRINKLE | EQ 10MG BASE | CAPSULE / ORAL | RLD | 2018-12-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208647-003 | EZALLOR SPRINKLE | EQ 20MG BASE | CAPSULE / ORAL | RLD | 2018-12-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208647-004 | EZALLOR SPRINKLE | EQ 40MG BASE | CAPSULE / ORAL | RLD | 2018-12-18 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208647-001 | EZALLOR SPRINKLE | EQ 5MG BASE | CAPSULE / ORAL | RLD | 2018-12-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208647-002 | EZALLOR SPRINKLE | EQ 10MG BASE | CAPSULE / ORAL | RLD | 2018-12-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208647-003 | EZALLOR SPRINKLE | EQ 20MG BASE | CAPSULE / ORAL | RLD | 2018-12-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208647-004 | EZALLOR SPRINKLE | EQ 40MG BASE | CAPSULE / ORAL | RLD | 2018-12-18 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208647-001 | EZALLOR SPRINKLE | EQ 5MG BASE | CAPSULE / ORAL | RLD | 2018-12-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208647-002 | EZALLOR SPRINKLE | EQ 10MG BASE | CAPSULE / ORAL | RLD | 2018-12-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208647-003 | EZALLOR SPRINKLE | EQ 20MG BASE | CAPSULE / ORAL | RLD | 2018-12-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208647-004 | EZALLOR SPRINKLE | EQ 40MG BASE | CAPSULE / ORAL | RLD | 2018-12-18 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208647-001 | EZALLOR SPRINKLE | EQ 5MG BASE | CAPSULE / ORAL | RLD | 2018-12-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208647-002 | EZALLOR SPRINKLE | EQ 10MG BASE | CAPSULE / ORAL | RLD | 2018-12-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208647-003 | EZALLOR SPRINKLE | EQ 20MG BASE | CAPSULE / ORAL | RLD | 2018-12-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208647-004 | EZALLOR SPRINKLE | EQ 40MG BASE | CAPSULE / ORAL | RLD | 2018-12-18 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208647-001 | EZALLOR SPRINKLE | EQ 5MG BASE | CAPSULE / ORAL | RLD | 2018-12-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208647-002 | EZALLOR SPRINKLE | EQ 10MG BASE | CAPSULE / ORAL | RLD | 2018-12-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208647-003 | EZALLOR SPRINKLE | EQ 20MG BASE | CAPSULE / ORAL | RLD | 2018-12-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208647-004 | EZALLOR SPRINKLE | EQ 40MG BASE | CAPSULE / ORAL | RLD | 2018-12-18 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208647-001 | EZALLOR SPRINKLE | EQ 5MG BASE | CAPSULE / ORAL | RLD | 2018-12-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208647-002 | EZALLOR SPRINKLE | EQ 10MG BASE | CAPSULE / ORAL | RLD | 2018-12-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208647-003 | EZALLOR SPRINKLE | EQ 20MG BASE | CAPSULE / ORAL | RLD | 2018-12-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208647-004 | EZALLOR SPRINKLE | EQ 40MG BASE | CAPSULE / ORAL | RLD | 2018-12-18 | 5bbf6a4d5a75… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N208647-001 | 10413543 | 2036-02-12 | Drug product | 2019-10-09 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N208647-002 | 10413543 | 2036-02-12 | Drug product | 2019-10-09 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N208647-003 | 10413543 | 2036-02-12 | Drug product | 2019-10-09 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N208647-004 | 10413543 | 2036-02-12 | Drug product | 2019-10-09 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N208647-001 | 10413543 | 2036-02-12 | Drug product | 2019-10-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N208647-002 | 10413543 | 2036-02-12 | Drug product | 2019-10-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N208647-003 | 10413543 | 2036-02-12 | Drug product | 2019-10-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N208647-004 | 10413543 | 2036-02-12 | Drug product | 2019-10-09 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208647-001 | 10413543 | 2036-02-12 | Drug product | 2019-10-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208647-002 | 10413543 | 2036-02-12 | Drug product | 2019-10-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208647-003 | 10413543 | 2036-02-12 | Drug product | 2019-10-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208647-004 | 10413543 | 2036-02-12 | Drug product | 2019-10-09 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208647-001 | 10413543 | 2036-02-12 | Drug product | 2019-10-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208647-002 | 10413543 | 2036-02-12 | Drug product | 2019-10-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208647-003 | 10413543 | 2036-02-12 | Drug product | 2019-10-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208647-004 | 10413543 | 2036-02-12 | Drug product | 2019-10-09 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208647-001 | 10413543 | 2036-02-12 | Drug product | 2019-10-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208647-002 | 10413543 | 2036-02-12 | Drug product | 2019-10-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208647-003 | 10413543 | 2036-02-12 | Drug product | 2019-10-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208647-004 | 10413543 | 2036-02-12 | Drug product | 2019-10-09 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208647-001 | 10413543 | 2036-02-12 | Drug product | 2019-10-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208647-002 | 10413543 | 2036-02-12 | Drug product | 2019-10-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208647-003 | 10413543 | 2036-02-12 | Drug product | 2019-10-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208647-004 | 10413543 | 2036-02-12 | Drug product | 2019-10-09 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208647-001 | 10413543 | 2036-02-12 | Drug product | 2019-10-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208647-002 | 10413543 | 2036-02-12 | Drug product | 2019-10-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208647-003 | 10413543 | 2036-02-12 | Drug product | 2019-10-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208647-004 | 10413543 | 2036-02-12 | Drug product | 2019-10-09 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208647-001 | 10413543 | 2036-02-12 | Drug product | 2019-10-09 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208647-002 | 10413543 | 2036-02-12 | Drug product | 2019-10-09 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208647-003 | 10413543 | 2036-02-12 | Drug product | 2019-10-09 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208647-004 | 10413543 | 2036-02-12 | Drug product | 2019-10-09 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208647-001 | 10413543 | 2036-02-12 | Drug product | 2019-10-09 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208647-002 | 10413543 | 2036-02-12 | Drug product | 2019-10-09 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208647-003 | 10413543 | 2036-02-12 | Drug product | 2019-10-09 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208647-004 | 10413543 | 2036-02-12 | Drug product | 2019-10-09 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208647-001 | 10413543 | 2036-02-12 | Drug product | 2019-10-09 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208647-002 | 10413543 | 2036-02-12 | Drug product | 2019-10-09 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208647-003 | 10413543 | 2036-02-12 | Drug product | 2019-10-09 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208647-004 | 10413543 | 2036-02-12 | Drug product | 2019-10-09 | 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 |
|---|---|---|---|---|---|---|
| Rosuvastatin calcium | ROSUVASTATIN CALCIUM | Proficient Rx LP | a1b4d50b-eda3-437c-9c80-4d854361ddc2 | 2022-11-01 | Warnings, Adverse reactions | ROSUVASTATIN CALCIUM |
| Rosuvastatin calcium | ROSUVASTATIN CALCIUM | Proficient Rx LP | 5a874865-3cbe-4589-9787-046feb9a2c46 | 2022-11-01 | Warnings, Adverse reactions | ROSUVASTATIN CALCIUM |
| Rosuvastatin Calcium | ROSUVASTATIN CALCIUM | Proficient Rx LP | a9478b12-89d2-42a4-a310-707a87ef43d7 | 2022-08-01 | Warnings, Adverse reactions | ROSUVASTATIN CALCIUM |
| Rosuvastatin Calcium | ROSUVASTATIN CALCIUM | Proficient Rx LP | 3066f572-e3db-4bf8-b9ee-bd32d9ed8c13 | 2022-06-01 | Warnings, Adverse reactions | ROSUVASTATIN CALCIUM |
| Rosuvastatin Calcium | ROSUVASTATIN CALCIUM | Proficient Rx LP | dcc22d05-cff6-42f9-b9fa-930f2084753f | 2022-05-01 | Warnings, Adverse reactions | ROSUVASTATIN CALCIUM |
| Rosuvastatin Calcium | ROSUVASTATIN CALCIUM | Proficient Rx LP | c40d5c38-3585-47ed-ad81-6ad2da91c9c8 | 2022-04-01 | Warnings, Adverse reactions | ROSUVASTATIN CALCIUM |
| Rosuvastatin calcium | ROSUVASTATIN CALCIUM | Aphena Pharma Solutions - Tennessee, LLC | a5ee9510-e691-49ec-a5cd-49e70371ee4d | 2019-01-09 | Warnings, Adverse reactions | ROSUVASTATIN CALCIUM |
| Rosuvastatin calcium | ROSUVASTATIN CALCIUM | Aphena Pharma Solutions - Tennessee, LLC | 410a0a03-6751-4c3d-82bf-c7c6a4081fdd | 2018-11-13 | Warnings, Adverse reactions | ROSUVASTATIN CALCIUM |
| Rosuvastatin calcium | ROSUVASTATIN CALCIUM | Aphena Pharma Solutions - Tennessee, LLC | cbef0681-705c-48fd-add9-1042658ef85d | 2018-09-12 | Warnings, Adverse reactions | ROSUVASTATIN CALCIUM |
| Rosuvastatin calcium | ROSUVASTATIN CALCIUM | Aphena Pharma Solutions - Tennessee, LLC | 69dfa637-2a81-4c7e-8fef-d4b4ab4c3f25 | 2018-06-30 | Warnings, Adverse reactions | ROSUVASTATIN 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 |
|---|---|---|---|---|---|
| 47335-984 | EZALLOR SPRINKLE | ROSUVASTATIN | Sun Pharmaceutical Industries, Inc. | NDA | Current |
| 47335-984 | EZALLOR SPRINKLE | ROSUVASTATIN | Sun Pharmaceutical Industries, Inc. | NDA | Current |
| 47335-984 | EZALLOR SPRINKLE | ROSUVASTATIN | Sun Pharmaceutical Industries, Inc. | NDA | Current |
| 47335-984 | EZALLOR SPRINKLE | ROSUVASTATIN | Sun Pharmaceutical Industries, Inc. | NDA | Current |
| 47335-985 | EZALLOR SPRINKLE | ROSUVASTATIN | Sun Pharmaceutical Industries, Inc. | NDA | Current |
| 47335-985 | EZALLOR SPRINKLE | ROSUVASTATIN | Sun Pharmaceutical Industries, Inc. | NDA | Current |
| 47335-985 | EZALLOR SPRINKLE | ROSUVASTATIN | Sun Pharmaceutical Industries, Inc. | NDA | Current |
| 47335-985 | EZALLOR SPRINKLE | ROSUVASTATIN | Sun Pharmaceutical Industries, Inc. | NDA | Current |
| 47335-986 | EZALLOR SPRINKLE | ROSUVASTATIN | Sun Pharmaceutical Industries, Inc. | NDA | Current |
| 47335-986 | EZALLOR SPRINKLE | ROSUVASTATIN | Sun Pharmaceutical Industries, Inc. | NDA | Current |
| 47335-986 | EZALLOR SPRINKLE | ROSUVASTATIN | Sun Pharmaceutical Industries, Inc. | NDA | Current |
| 47335-986 | EZALLOR SPRINKLE | ROSUVASTATIN | Sun Pharmaceutical Industries, Inc. | NDA | Current |
| 47335-987 | EZALLOR SPRINKLE | ROSUVASTATIN | Sun Pharmaceutical Industries, Inc. | NDA | Current |
| 47335-987 | EZALLOR SPRINKLE | ROSUVASTATIN | Sun Pharmaceutical Industries, Inc. | NDA | Current |
| 47335-987 | EZALLOR SPRINKLE | ROSUVASTATIN | Sun Pharmaceutical Industries, Inc. | NDA | Current |
| 47335-987 | EZALLOR SPRINKLE | ROSUVASTATIN | Sun Pharmaceutical Industries, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 81254 | SUPPL | 2025-02-14 |
| 81238 | SUPPL | 2025-02-13 |
| 77909 | SUPPL | 2024-03-21 |
| 77897 | SUPPL | 2024-03-21 |
| 75018 | SUPPL | 2023-08-07 |
| 75017 | SUPPL | 2023-08-07 |
| 75016 | SUPPL | 2023-08-07 |
| 75015 | SUPPL | 2023-08-07 |
| 75014 | SUPPL | 2023-08-07 |
| 75013 | SUPPL | 2023-08-07 |
| 75008 | SUPPL | 2023-08-07 |
| 75007 | SUPPL | 2023-08-07 |
| 75006 | SUPPL | 2023-08-07 |
| 75005 | SUPPL | 2023-08-07 |
| 75004 | SUPPL | 2023-08-07 |
| 75003 | SUPPL | 2023-08-07 |
| 64721 | SUPPL | 2020-09-29 |
| 64708 | SUPPL | 2020-09-28 |
| 62608 | SUPPL | 2020-04-20 |
| 62598 | SUPPL | 2020-04-20 |
| 59643 | ORIG | 2019-08-09 |
| 58192 | SUPPL | 2019-04-02 |
| 58135 | SUPPL | 2019-03-29 |
| 56935 | ORIG | 2018-12-21 |
| 56799 | ORIG | 2018-12-19 |