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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019885
Company: PFIZER PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACCUPRIL QUINAPRIL HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Prescription AB Yes No
ACCUPRIL QUINAPRIL HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription AB Yes No
ACCUPRIL QUINAPRIL HYDROCHLORIDE EQ 20MG BASE TABLET;ORAL Prescription AB Yes No
ACCUPRIL QUINAPRIL HYDROCHLORIDE EQ 40MG BASE TABLET;ORAL Prescription AB Yes Yes
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/26/2017 SUPPL-43 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019885s043lbl.pdf
02/13/2017 SUPPL-42 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019885s042lbl.pdf
09/11/2015 SUPPL-41 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019885s041lbl.pdf
05/02/2014 SUPPL-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019885s040lbl.pdf
10/25/2013 SUPPL-39 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019885s039lbl.pdf
09/23/2013 SUPPL-38 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019885s038lbl.pdf
04/09/2013 SUPPL-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019885s037lbl.pdf
09/21/2012 SUPPL-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019885s036lbl.pdf
01/18/2012 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019885s035lbl.pdf
10/14/2011 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019885s033lbl.pdf
09/18/2009 SUPPL-28 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019885s028lbl.pdf
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