Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077093
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 12.5MG;EQ 10MG BASE TABLET;ORAL Discontinued None No No
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 12.5MG;EQ 20MG BASE TABLET;ORAL Discontinued None No No
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 25MG;EQ 20MG 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
03/28/2005 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
02/16/2016 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

04/24/2015 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

04/24/2015 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

04/24/2015 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

04/24/2015 SUPPL-10 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

01/10/2011 SUPPL-8 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

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