Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019888
Company: ALVOGEN MALTA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZESTORETIC HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5MG;20MG TABLET;ORAL Prescription AB Yes Yes
ZESTORETIC HYDROCHLOROTHIAZIDE; LISINOPRIL 25MG;20MG TABLET;ORAL Prescription AB Yes Yes
ZESTORETIC HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5MG;10MG TABLET;ORAL Prescription AB Yes 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
07/20/1989 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/21/2017 SUPPL-67 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019888s067lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019888Orig1s067ltr.pdf
08/25/2015 SUPPL-65 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019888s065lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019888Orig1s065ltr.pdf
12/24/2014 SUPPL-56 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019888s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019888Orig1s056ltr.pdf
11/05/2013 SUPPL-55 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019888s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019888Orig1s055ltr.pdf
08/13/2012 SUPPL-54 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019888s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019888Orig1s054ltr.pdf
10/31/2012 SUPPL-53 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019888s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019888Orig1s053ltr.pdf
03/29/2012 SUPPL-52 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019888s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019888s052ltr.pdf
05/02/2012 SUPPL-51 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019888s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019888s051ltr.pdf
08/04/2011 SUPPL-50 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019888s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019888s050ltr.pdf
03/11/2011 SUPPL-49 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019888s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019888s049,021093s012ltr.pdf
11/06/2009 SUPPL-47 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019888s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019888s047ltr.pdf
05/20/2009 SUPPL-45 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019888s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019888s045ltr.pdf
10/04/2007 SUPPL-44 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019777s053, 019888s044ltr.pdf
07/16/2007 SUPPL-43 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019777s052, 019888s043ltr.pdf
06/16/2006 SUPPL-41 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019777s050, 019888s041LTR.pdf
05/24/2005 SUPPL-40 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019888s040ltr.pdf
10/17/2002 SUPPL-36 Labeling

Label is not available on this site.

04/17/2003 SUPPL-35 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19888slr035ltr.pdf
12/18/2001 SUPPL-34 Labeling

Label is not available on this site.

12/19/2000 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

12/15/2000 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

07/27/2000 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

11/18/1999 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

05/08/1998 SUPPL-29 Labeling

Label is not available on this site.

01/14/1997 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

10/11/1996 SUPPL-27 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/05/1996 SUPPL-26 Labeling

Label is not available on this site.

12/14/1995 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

01/05/1996 SUPPL-24 Labeling

Label is not available on this site.

07/11/1995 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

10/26/1995 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

03/31/1995 SUPPL-21 Labeling

Label is not available on this site.

06/13/1995 SUPPL-20 Labeling Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019888s020_zestoretic_toc.cfm
09/15/1994 SUPPL-19 Labeling

Label is not available on this site.

08/05/1994 SUPPL-18 Labeling

Label is not available on this site.

08/05/1994 SUPPL-17 Labeling

Label is not available on this site.

12/09/1993 SUPPL-16 Labeling

Label is not available on this site.

06/13/1995 SUPPL-15 Labeling

Label is not available on this site.

09/23/1993 SUPPL-14 Labeling

Label is not available on this site.

08/05/1994 SUPPL-13 Labeling

Label is not available on this site.

03/31/1993 SUPPL-12 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/19888-S12_Zestril.pdf
11/18/1993 SUPPL-11 Efficacy-New Dosing Regimen

Label is not available on this site.

11/18/1992 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

06/25/1992 SUPPL-9 Labeling

Label is not available on this site.

12/11/1991 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

04/11/1991 SUPPL-7 Labeling

Label is not available on this site.

04/08/1991 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

02/21/1991 SUPPL-5 Labeling

Label is not available on this site.

12/21/1990 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

11/08/1990 SUPPL-3 Labeling

Label is not available on this site.

09/20/1990 SUPPL-2 Manufacturing (CMC)-Formulation

Label is not available on this site.

10/13/1989 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/21/2017 SUPPL-67 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019888s067lbl.pdf
08/25/2015 SUPPL-65 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019888s065lbl.pdf
12/24/2014 SUPPL-56 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019888s056lbl.pdf
11/05/2013 SUPPL-55 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019888s055lbl.pdf
10/31/2012 SUPPL-53 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019888s053lbl.pdf
08/13/2012 SUPPL-54 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019888s054lbl.pdf
05/02/2012 SUPPL-51 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019888s051lbl.pdf
03/29/2012 SUPPL-52 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019888s052lbl.pdf
08/04/2011 SUPPL-50 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019888s050lbl.pdf
03/11/2011 SUPPL-49 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019888s049lbl.pdf
11/06/2009 SUPPL-47 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019888s047lbl.pdf
05/20/2009 SUPPL-45 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019888s045lbl.pdf

ZESTORETIC

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 075776 HERITAGE PHARMA
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 076113 MYLAN
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 MALTA

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 075776 HERITAGE PHARMA
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 076113 MYLAN
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 MALTA

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 075776 HERITAGE PHARMA
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 076113 MYLAN
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 MALTA

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