Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075869
Company: TEVA
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
07/01/2002 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75869TA.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/07/2020 SUPPL-18 Labeling-Package Insert

Label is not available on this site.

07/07/2020 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

03/27/2009 SUPPL-16 Labeling

Label is not available on this site.

01/19/2007 SUPPL-12 Labeling

Label is not available on this site.

05/01/2006 SUPPL-11 Labeling

Label is not available on this site.

10/20/2004 SUPPL-9 Labeling

Label is not available on this site.

07/14/2003 SUPPL-4 Labeling

Label is not available on this site.

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