Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 076113
Company: MYLAN
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/2002/76113tadF.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/20/2020 SUPPL-38 Labeling-Package Insert

Label is not available on this site.

05/21/2018 SUPPL-36 Labeling-Package Insert

Label is not available on this site.

05/21/2018 SUPPL-34 Labeling-Package Insert

Label is not available on this site.

05/21/2018 SUPPL-31 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

05/21/2018 SUPPL-30 Labeling-Package Insert

Label is not available on this site.

05/21/2018 SUPPL-29 Labeling-Package Insert

Label is not available on this site.

02/26/2014 SUPPL-26 Labeling-Container/Carton Labels

Label is not available on this site.

09/06/2013 SUPPL-25 Labeling-Package Insert

Label is not available on this site.

09/06/2013 SUPPL-24 Labeling-Package Insert

Label is not available on this site.

02/25/2010 SUPPL-23 Labeling-Package Insert

Label is not available on this site.

02/25/2010 SUPPL-19 Labeling-Container/Carton Labels

Label is not available on this site.

12/04/2007 SUPPL-10 Labeling

Label is not available on this site.

09/23/2004 SUPPL-4 Labeling

Label is not available on this site.

06/06/2003 SUPPL-2 Labeling

Label is not available on this site.

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English