Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075451
Company: AUROBINDO PHARMA USA
Company: AUROBINDO PHARMA USA
| 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 |
|---|---|---|---|---|---|---|---|
| 12/17/2001 | 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 |
|---|---|---|---|---|---|
| 09/25/2020 | SUPPL-25 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/04/2017 | SUPPL-24 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/02/2014 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/29/2013 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/29/2012 | SUPPL-19 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/03/2014 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 02/12/2007 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 04/20/2005 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 10/11/2002 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/11/2002 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |