Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076694
Company: NORVIUM BIOSCIENCE
Company: NORVIUM BIOSCIENCE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
QUINAPRIL HYDROCHLORIDE | QUINAPRIL HYDROCHLORIDE | EQ 5MG BASE | TABLET;ORAL | Discontinued | None | No | No |
QUINAPRIL HYDROCHLORIDE | QUINAPRIL HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Discontinued | None | No | No |
QUINAPRIL HYDROCHLORIDE | QUINAPRIL HYDROCHLORIDE | EQ 20MG BASE | TABLET;ORAL | Discontinued | None | No | No |
QUINAPRIL HYDROCHLORIDE | QUINAPRIL HYDROCHLORIDE | EQ 40MG BASE | 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 |
---|---|---|---|---|---|---|---|
12/23/2004 | 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 |
---|---|---|---|---|---|
02/17/2011 | SUPPL-10 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
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04/28/2006 | SUPPL-5 | Labeling |
Label is not available on this site. |