Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 208647
Company: SUN PHARM
Company: SUN PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| EZALLOR SPRINKLE | ROSUVASTATIN CALCIUM | EQ 5MG BASE | CAPSULE;ORAL | Discontinued | None | Yes | No |
| EZALLOR SPRINKLE | ROSUVASTATIN CALCIUM | EQ 10MG BASE | CAPSULE;ORAL | Discontinued | None | Yes | No |
| EZALLOR SPRINKLE | ROSUVASTATIN CALCIUM | EQ 20MG BASE | CAPSULE;ORAL | Discontinued | None | Yes | No |
| EZALLOR SPRINKLE | ROSUVASTATIN CALCIUM | EQ 40MG BASE | CAPSULE;ORAL | Discontinued | None | Yes | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/18/2018 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208647s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208647Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208647Orig1s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/20/2024 | SUPPL-13 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208647s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/208647Orig1s013ltr.pdf | |
| 08/04/2023 | SUPPL-11 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208647s006s007s008s009s010s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208647Orig1s006,s007,s008,s009,s010,s011ltr.pdf | |
| 08/04/2023 | SUPPL-10 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208647s006s007s008s009s010s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208647Orig1s006,s007,s008,s009,s010,s011ltr.pdf | |
| 08/04/2023 | SUPPL-9 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208647s006s007s008s009s010s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208647Orig1s006,s007,s008,s009,s010,s011ltr.pdf | |
| 08/04/2023 | SUPPL-8 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208647s006s007s008s009s010s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208647Orig1s006,s007,s008,s009,s010,s011ltr.pdf | |
| 08/04/2023 | SUPPL-7 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208647s006s007s008s009s010s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208647Orig1s006,s007,s008,s009,s010,s011ltr.pdf | |
| 08/04/2023 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208647s006s007s008s009s010s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208647Orig1s006,s007,s008,s009,s010,s011ltr.pdf | |
| 09/25/2020 | SUPPL-4 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208647s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208647Orig1s004ltr.pdf | |
| 04/17/2020 | SUPPL-2 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208647s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208647Orig1s002ltr.pdf | |
| 03/27/2019 | SUPPL-1 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208647s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208647Orig1s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/20/2024 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208647s013lbl.pdf | |
| 03/20/2024 | SUPPL-13 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208647s013lbl.pdf | |
| 08/04/2023 | SUPPL-11 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208647s006s007s008s009s010s011lbl.pdf | |
| 08/04/2023 | SUPPL-10 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208647s006s007s008s009s010s011lbl.pdf | |
| 08/04/2023 | SUPPL-9 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208647s006s007s008s009s010s011lbl.pdf | |
| 08/04/2023 | SUPPL-8 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208647s006s007s008s009s010s011lbl.pdf | |
| 08/04/2023 | SUPPL-7 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208647s006s007s008s009s010s011lbl.pdf | |
| 08/04/2023 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208647s006s007s008s009s010s011lbl.pdf | |
| 09/25/2020 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208647s004lbl.pdf | |
| 09/25/2020 | SUPPL-4 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208647s004lbl.pdf | |
| 04/17/2020 | SUPPL-2 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208647s002lbl.pdf | |
| 04/17/2020 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208647s002lbl.pdf | |
| 03/27/2019 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208647s001lbl.pdf | |
| 03/27/2019 | SUPPL-1 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208647s001lbl.pdf | |
| 12/18/2018 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208647s000lbl.pdf |