Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076285
Company: SUN PHARM INDS LTD
Company: SUN PHARM INDS LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SIMVASTATIN | SIMVASTATIN | 5MG | TABLET;ORAL | Discontinued | None | No | No |
| SIMVASTATIN | SIMVASTATIN | 10MG | TABLET;ORAL | Discontinued | None | No | No |
| SIMVASTATIN | SIMVASTATIN | 20MG | TABLET;ORAL | Discontinued | None | No | No |
| SIMVASTATIN | SIMVASTATIN | 40MG | TABLET;ORAL | Discontinued | None | No | No |
| SIMVASTATIN | SIMVASTATIN | 80MG | TABLET;ORAL | Discontinued | None | No | 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 |
|---|---|---|---|---|---|---|---|
| 06/23/2006 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076285s000LTR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/05/2009 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 06/18/2008 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 12/20/2006 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 12/20/2006 | SUPPL-3 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
||
| 12/20/2006 | SUPPL-2 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |