Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019888
Company: ALMATICA
Company: ALMATICA
| 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 | No |
| ZESTORETIC | HYDROCHLOROTHIAZIDE; LISINOPRIL | 25MG;20MG | TABLET;ORAL | Prescription | AB | Yes | No |
| 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 |
|---|---|---|---|---|---|
| 08/20/2020 | SUPPL-69 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019888s069lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/019888Orig1s069ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 08/20/2020 | SUPPL-69 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019888s069lbl.pdf | |
| 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 | 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 | ALMATICA |
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 | 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 | ALMATICA |
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 | 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 | ALMATICA |