Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076694
Company: MYLAN
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-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

04/28/2006 SUPPL-5 Labeling

Label is not available on this site.

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