Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076607
Company: SUN PHARM INDS LTD
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
12/15/2004 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/076607ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/25/2015 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

03/09/2015 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

03/09/2015 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

03/09/2015 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

03/09/2015 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

12/14/2012 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

12/14/2012 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

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