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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019851
Company: VALIDUS PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LOTENSIN BENAZEPRIL HYDROCHLORIDE 5MG TABLET;ORAL Discontinued None 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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/07/2019 SUPPL-54 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019851s054lbl.pdf
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
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