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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076374
Company: CHARTWELL RX

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
03/31/2004 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76374.ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/27/2022 SUPPL-13 Labeling-Package Insert

Label is not available on this site.
05/27/2022 SUPPL-12 Labeling-Package Insert

Label is not available on this site.
05/27/2022 SUPPL-11 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.
11/06/2019 SUPPL-10 Labeling-Package Insert

Label is not available on this site.
02/11/2016 SUPPL-9 Labeling-Package Insert

Label is not available on this site.
02/11/2016 SUPPL-8 Labeling-Package Insert

Label is not available on this site.
02/11/2016 SUPPL-7 Labeling-Package Insert

Label is not available on this site.
09/23/2004 SUPPL-1 Labeling

Label is not available on this site.
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