Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019851
Company: US PHARMS HOLDINGS I
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LOTENSIN BENAZEPRIL HYDROCHLORIDE 5MG TABLET;ORAL Prescription AB Yes No
LOTENSIN BENAZEPRIL HYDROCHLORIDE 10MG TABLET;ORAL Prescription AB Yes No
LOTENSIN BENAZEPRIL HYDROCHLORIDE 20MG TABLET;ORAL Prescription AB Yes No
LOTENSIN BENAZEPRIL HYDROCHLORIDE 40MG TABLET;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/25/1991 ORIG-1 Approval Type 1 - New Molecular Entity 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
08/03/2017 SUPPL-52 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019851s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019851Orig1s052ltr.pdf
12/17/2015 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

07/22/2015 SUPPL-49 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019851s045s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019851Orig1s045,s049ltr.pdf
07/14/2015 SUPPL-48 Manufacturing (CMC)

Label is not available on this site.

01/26/2015 SUPPL-47 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019851s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019851Orig1s047ltr.pdf
12/12/2014 SUPPL-46 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019851s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019851Orig1s046ltr.pdf
07/22/2015 SUPPL-45 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019851s045s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019851Orig1s045,s049ltr.pdf
09/21/2012 SUPPL-44 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019851s044lbl.pdf
01/19/2012 SUPPL-43 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019851s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019851s043,020033s045ltr.pdf
05/17/2012 SUPPL-42 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019851s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019851Orig1s042ltr.pdf
06/14/2011 SUPPL-40 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019851s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019851s040ltr.pdf
11/10/2009 SUPPL-38 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019851s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019851s038ltr.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-34 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-29 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19851slr029,20033slr025ltr.pdf
03/02/2004 SUPPL-28 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/019851s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19851se5-028ltr.pdf
10/25/2002 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

09/20/2002 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

04/29/2002 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

11/30/2001 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

08/13/2001 SUPPL-22 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/14/2001 SUPPL-21 Labeling

Label is not available on this site.

11/02/2000 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

05/10/2000 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

04/28/1999 SUPPL-18 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/20/1998 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

07/29/1998 SUPPL-16 Labeling

Label is not available on this site.

08/13/1997 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/18/1997 SUPPL-14 Manufacturing (CMC)-Packaging

Label is not available on this site.

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

Label is not available on this site.

06/25/1996 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

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

Label is not available on this site.

07/07/1995 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

11/22/1995 SUPPL-9 Labeling

Label is not available on this site.

02/08/1995 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

05/05/1995 SUPPL-7 Labeling

Label is not available on this site.

03/15/1994 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.

11/20/1992 SUPPL-4 Labeling

Label is not available on this site.

06/25/1992 SUPPL-3 Labeling

Label is not available on this site.

03/13/1992 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/09/1992 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/03/2017 SUPPL-52 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019851s052lbl.pdf
07/22/2015 SUPPL-49 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019851s045s049lbl.pdf
07/22/2015 SUPPL-45 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019851s045s049lbl.pdf
01/26/2015 SUPPL-47 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019851s047lbl.pdf
12/12/2014 SUPPL-46 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019851s046lbl.pdf
09/21/2012 SUPPL-44 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019851s044lbl.pdf
05/17/2012 SUPPL-42 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019851s042lbl.pdf
01/19/2012 SUPPL-43 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019851s043lbl.pdf
06/14/2011 SUPPL-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019851s040lbl.pdf
11/10/2009 SUPPL-38 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019851s038lbl.pdf
03/02/2004 SUPPL-28 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/019851s028lbl.pdf

LOTENSIN

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 076820 AMNEAL PHARMS
BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 077128 APOTEX INC
BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 076333 IVAX SUB TEVA PHARMS
BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 076430 MYLAN
BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 076118 PRINSTON INC
BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 076402 SANDOZ
BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 076344 SUN PHARM INDS LTD
BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 076211 TEVA
BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 078848 ZYDUS PHARMS USA
LOTENSIN BENAZEPRIL HYDROCHLORIDE 5MG TABLET;ORAL Prescription Yes AB 019851 US PHARMS HOLDINGS I

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 076820 AMNEAL PHARMS
BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 077128 APOTEX INC
BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 078212 AUROBINDO PHARMA
BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 076333 IVAX SUB TEVA PHARMS
BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 076430 MYLAN
BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 076118 PRINSTON INC
BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 076402 SANDOZ
BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 076344 SUN PHARM INDS LTD
BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 076211 TEVA
BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 078848 ZYDUS PHARMS USA
LOTENSIN BENAZEPRIL HYDROCHLORIDE 10MG TABLET;ORAL Prescription Yes AB 019851 US PHARMS HOLDINGS I

TABLET;ORAL; 20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 076820 AMNEAL PHARMS
BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 077128 APOTEX INC
BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 078212 AUROBINDO PHARMA
BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 076333 IVAX SUB TEVA PHARMS
BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 076430 MYLAN
BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 076118 PRINSTON INC
BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 076402 SANDOZ
BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 076344 SUN PHARM INDS LTD
BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 076211 TEVA
BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 078848 ZYDUS PHARMS USA
LOTENSIN BENAZEPRIL HYDROCHLORIDE 20MG TABLET;ORAL Prescription Yes AB 019851 US PHARMS HOLDINGS I

TABLET;ORAL; 40MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE 40MG TABLET;ORAL Prescription No AB 076820 AMNEAL PHARMS
BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE 40MG TABLET;ORAL Prescription No AB 077128 APOTEX INC
BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE 40MG TABLET;ORAL Prescription No AB 078212 AUROBINDO PHARMA
BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE 40MG TABLET;ORAL Prescription No AB 076333 IVAX SUB TEVA PHARMS
BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE 40MG TABLET;ORAL Prescription No AB 076430 MYLAN
BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE 40MG TABLET;ORAL Prescription No AB 076118 PRINSTON INC
BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE 40MG TABLET;ORAL Prescription No AB 076402 SANDOZ
BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE 40MG TABLET;ORAL Prescription No AB 076344 SUN PHARM INDS LTD
BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE 40MG TABLET;ORAL Prescription No AB 076211 TEVA
BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE 40MG TABLET;ORAL Prescription No AB 078848 ZYDUS PHARMS USA
LOTENSIN BENAZEPRIL HYDROCHLORIDE 40MG TABLET;ORAL Prescription Yes AB 019851 US PHARMS HOLDINGS I

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