Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020033
Company: US PHARMS HOLDINGS I
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LOTENSIN HCT BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 5MG;6.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
LOTENSIN HCT BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET;ORAL Prescription AB Yes No
LOTENSIN HCT BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20MG;25MG TABLET;ORAL Prescription AB Yes Yes
LOTENSIN HCT BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20MG;12.5MG 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
05/19/1992 ORIG-1 Approval Type 4 - New Combination 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
08/08/2018 SUPPL-62 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020033s0062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020033Orig1s062ltr.pdf
08/03/2017 SUPPL-61 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020033s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020033Orig1s061ltr.pdf
05/05/2016 SUPPL-55 Manufacturing (CMC)

Label is not available on this site.

06/03/2016 SUPPL-54 Manufacturing (CMC)

Label is not available on this site.

02/12/2016 SUPPL-53 Manufacturing (CMC)

Label is not available on this site.

08/25/2015 SUPPL-52 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020033s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020033Orig1s052ltr.pdf
07/07/2015 SUPPL-51 Manufacturing (CMC)

Label is not available on this site.

12/12/2014 SUPPL-50 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020033s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020033Orig1s050ltr.pdf
08/14/2014 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

07/22/2014 SUPPL-48 Manufacturing (CMC)

Label is not available on this site.

09/21/2012 SUPPL-47 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020033s047lbl.pdf
07/27/2012 SUPPL-46 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020033s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020033Orig1s046ltr.pdf
01/19/2012 SUPPL-45 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020033s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019851s043,020033s045ltr.pdf
02/16/2012 SUPPL-43 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020033s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020033s043ltr.pdf
06/14/2011 SUPPL-41 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020033s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020033s041ltr.pdf
03/17/2011 SUPPL-40 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020033s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020033s040ltr.pdf
11/10/2009 SUPPL-38 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020033s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020033s038ltr.pdf
01/22/2009 SUPPL-37 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019851s037,020033s037ltr.pdf
05/29/2008 SUPPL-36 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019851s036, 020033s036ltr.pdf
02/02/2007 SUPPL-33 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019851s034, 020033s033ltr.pdf
10/29/2003 SUPPL-25 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19851slr029,20033slr025ltr.pdf
10/25/2002 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

09/20/2002 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

04/29/2002 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

11/30/2001 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

08/13/2001 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/14/2001 SUPPL-18 Labeling

Label is not available on this site.

05/10/2000 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

10/16/2001 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

04/28/1999 SUPPL-14 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/29/1998 SUPPL-13 Labeling

Label is not available on this site.

04/09/1997 SUPPL-12 Labeling

Label is not available on this site.

01/13/1997 SUPPL-11 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

11/02/1995 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

04/02/1996 SUPPL-9 Labeling

Label is not available on this site.

05/05/1995 SUPPL-8 Labeling

Label is not available on this site.

12/20/1993 SUPPL-7 Labeling

Label is not available on this site.

06/30/1993 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

10/21/1993 SUPPL-5 Labeling

Label is not available on this site.

11/25/1992 SUPPL-4 Labeling

Label is not available on this site.

01/07/1993 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/23/1992 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

06/23/1992 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/08/2018 SUPPL-62 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020033s0062lbl.pdf
08/03/2017 SUPPL-61 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020033s061lbl.pdf
08/25/2015 SUPPL-52 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020033s052lbl.pdf
12/12/2014 SUPPL-50 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020033s050lbl.pdf
09/21/2012 SUPPL-47 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020033s047lbl.pdf
07/27/2012 SUPPL-46 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020033s046lbl.pdf
02/16/2012 SUPPL-43 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020033s043lbl.pdf
01/19/2012 SUPPL-45 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020033s045lbl.pdf
06/14/2011 SUPPL-41 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020033s041lbl.pdf
03/17/2011 SUPPL-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020033s040lbl.pdf
11/10/2009 SUPPL-38 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020033s038lbl.pdf

LOTENSIN HCT

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET;ORAL Prescription No AB 078794 APOTEX INC
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET;ORAL Prescription No AB 076688 MYLAN
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET;ORAL Prescription No AB 076631 SANDOZ
LOTENSIN HCT BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET;ORAL Prescription Yes AB 020033 US PHARMS HOLDINGS I

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20MG;25MG TABLET;ORAL Prescription No AB 078794 APOTEX INC
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20MG;25MG TABLET;ORAL Prescription No AB 076688 MYLAN
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20MG;25MG TABLET;ORAL Prescription No AB 076631 SANDOZ
LOTENSIN HCT BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20MG;25MG TABLET;ORAL Prescription Yes AB 020033 US PHARMS HOLDINGS I

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET;ORAL Prescription No AB 078794 APOTEX INC
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET;ORAL Prescription No AB 076688 MYLAN
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET;ORAL Prescription No AB 076631 SANDOZ
LOTENSIN HCT BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET;ORAL Prescription Yes AB 020033 US PHARMS HOLDINGS I

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