Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077489
Company: TEVA PHARMS
Company: TEVA PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TRANDOLAPRIL | TRANDOLAPRIL | 1MG | TABLET;ORAL | Discontinued | None | No | No |
TRANDOLAPRIL | TRANDOLAPRIL | 2MG | TABLET;ORAL | Discontinued | None | No | No |
TRANDOLAPRIL | TRANDOLAPRIL | 4MG | 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 |
---|---|---|---|---|---|---|---|
12/12/2006 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077489s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/31/2015 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
08/31/2015 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
08/31/2015 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
08/31/2015 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
07/06/2010 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
12/11/2009 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
05/25/2007 | SUPPL-2 | Labeling |
Label is not available on this site. |