Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077520
Company: SUN PHARM INDUSTRIES
Company: SUN PHARM INDUSTRIES
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LOVASTATIN | LOVASTATIN | 10MG | TABLET;ORAL | Discontinued | None | No | No |
| LOVASTATIN | LOVASTATIN | 20MG | TABLET;ORAL | Discontinued | None | No | No |
| LOVASTATIN | LOVASTATIN | 40MG | 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 |
|---|---|---|---|---|---|---|---|
| 04/14/2006 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/24/2024 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/04/2017 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/02/2014 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/29/2012 | SUPPL-9 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 05/01/2012 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/05/2007 | SUPPL-4 | Labeling |
Label is not available on this site. |