Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 077912
Company: LUPIN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5MG;10MG TABLET;ORAL Prescription AB No No
LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5MG;20MG TABLET;ORAL Prescription AB No No
LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 25MG;20MG TABLET;ORAL Prescription AB 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
09/27/2006 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
02/28/2014 SUPPL-23 Labeling-Package Insert

Label is not available on this site.

02/28/2014 SUPPL-20 Labeling-Package Insert

Label is not available on this site.

02/28/2014 SUPPL-19 Labeling-Package Insert

Label is not available on this site.

08/31/2009 SUPPL-8 Labeling

Label is not available on this site.

01/11/2007 SUPPL-1 Labeling

Label is not available on this site.

LISINOPRIL AND HYDROCHLOROTHIAZIDE

TABLET;ORAL; 12.5MG;10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5MG;10MG TABLET;ORAL Prescription No AB 077606 AUROBINDO
LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5MG;10MG TABLET;ORAL Prescription No AB 076265 HIKMA INTL PHARMS
LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5MG;10MG TABLET;ORAL Prescription No AB 204058 INVAGEN PHARMS
LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5MG;10MG TABLET;ORAL Prescription No AB 077912 LUPIN
LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5MG;10MG TABLET;ORAL Prescription No AB 076230 PRINSTON INC
LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5MG;10MG TABLET;ORAL Prescription No AB 076262 SANDOZ
LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5MG;10MG TABLET;ORAL Prescription No AB 076007 SUN PHARM INDS LTD
LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5MG;10MG TABLET;ORAL Prescription No AB 076194 WATSON LABS
ZESTORETIC HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5MG;10MG TABLET;ORAL Prescription Yes AB 019888 ALVOGEN

TABLET;ORAL; 12.5MG;20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5MG;20MG TABLET;ORAL Prescription No AB 077606 AUROBINDO
LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5MG;20MG TABLET;ORAL Prescription No AB 076265 HIKMA INTL PHARMS
LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5MG;20MG TABLET;ORAL Prescription No AB 204058 INVAGEN PHARMS
LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5MG;20MG TABLET;ORAL Prescription No AB 077912 LUPIN
LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5MG;20MG TABLET;ORAL Prescription No AB 076230 PRINSTON INC
LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5MG;20MG TABLET;ORAL Prescription No AB 076262 SANDOZ
LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5MG;20MG TABLET;ORAL Prescription No AB 076007 SUN PHARM INDS LTD
LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5MG;20MG TABLET;ORAL Prescription No AB 076194 WATSON LABS
ZESTORETIC HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5MG;20MG TABLET;ORAL Prescription Yes AB 019888 ALVOGEN

TABLET;ORAL; 25MG;20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 25MG;20MG TABLET;ORAL Prescription No AB 077606 AUROBINDO
LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 25MG;20MG TABLET;ORAL Prescription No AB 076265 HIKMA INTL PHARMS
LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 25MG;20MG TABLET;ORAL Prescription No AB 204058 INVAGEN PHARMS
LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 25MG;20MG TABLET;ORAL Prescription No AB 077912 LUPIN
LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 25MG;20MG TABLET;ORAL Prescription No AB 076230 PRINSTON INC
LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 25MG;20MG TABLET;ORAL Prescription No AB 076262 SANDOZ
LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 25MG;20MG TABLET;ORAL Prescription No AB 076007 SUN PHARM INDS LTD
LISINOPRIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LISINOPRIL 25MG;20MG TABLET;ORAL Prescription No AB 076194 WATSON LABS
ZESTORETIC HYDROCHLOROTHIAZIDE; LISINOPRIL 25MG;20MG TABLET;ORAL Prescription Yes AB 019888 ALVOGEN

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