Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076265
Company: HIKMA INTL PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5MG;10MG TABLET;ORAL Discontinued None No No
LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5MG;20MG TABLET;ORAL Discontinued None No No
LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 25MG;20MG 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
07/08/2002 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
08/20/2020 SUPPL-31 Labeling-Package Insert

Label is not available on this site.

08/03/2020 SUPPL-30 Labeling-Package Insert

Label is not available on this site.

08/03/2020 SUPPL-29 Labeling-Package Insert

Label is not available on this site.

05/26/2015 SUPPL-26 Labeling-Package Insert

Label is not available on this site.

05/26/2015 SUPPL-25 Labeling-Package Insert

Label is not available on this site.

05/26/2015 SUPPL-24 Labeling-Package Insert

Label is not available on this site.

05/26/2015 SUPPL-23 Labeling-Package Insert

Label is not available on this site.

09/11/2013 SUPPL-20 Labeling-Package Insert

Label is not available on this site.

09/11/2013 SUPPL-18 Labeling-Package Insert

Label is not available on this site.

09/11/2013 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

03/03/2010 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

03/03/2010 SUPPL-14 Labeling

Label is not available on this site.

04/09/2007 SUPPL-9 Labeling

Label is not available on this site.

08/08/2006 SUPPL-7 Labeling

Label is not available on this site.

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