Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090790
Company: APOTEX CORP
Company: APOTEX CORP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 25MG | TABLET;ORAL | Discontinued | None | No | No |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 50MG | TABLET;ORAL | Discontinued | None | No | No |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 100MG | 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 |
|---|---|---|---|---|---|---|---|
| 10/06/2010 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2010/090790Orig1s000.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/10/2016 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/09/2015 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/09/2015 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/05/2014 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/05/2014 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/20/2012 | SUPPL-4 | Labeling-Patient Package Insert, Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/19/2011 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |