Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076348
Company: ANI PHARMS
Company: ANI PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | 5MG;6.25MG | TABLET;ORAL | Discontinued | None | No | No |
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | 10MG;12.5MG | TABLET;ORAL | Discontinued | None | No | No |
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | 20MG;12.5MG | TABLET;ORAL | Discontinued | None | No | No |
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | 20MG;25MG | 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 |
---|---|---|---|---|---|---|---|
02/11/2004 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76348ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/27/2009 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
08/22/2008 | SUPPL-9 | Labeling |
Label is not available on this site. |
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09/25/2007 | SUPPL-7 | Labeling |
Label is not available on this site. |