Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077833
Company: IMPAX LABS
Company: IMPAX LABS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NADOLOL AND BENDROFLUMETHIAZIDE | BENDROFLUMETHIAZIDE; NADOLOL | 5MG;40MG | TABLET;ORAL | Discontinued | None | No | No |
NADOLOL AND BENDROFLUMETHIAZIDE | BENDROFLUMETHIAZIDE; NADOLOL | 5MG;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 |
---|---|---|---|---|---|---|---|
03/30/2007 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077833s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/29/2024 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
04/26/2016 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |