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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 012151
Company: PFIZER
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALDACTONE SPIRONOLACTONE 50MG TABLET;ORAL Prescription AB Yes No
ALDACTONE SPIRONOLACTONE 25MG TABLET;ORAL Prescription AB Yes No
ALDACTONE SPIRONOLACTONE 100MG TABLET;ORAL Prescription AB Yes Yes
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/28/2020 SUPPL-77 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/012151s077lbl.pdf
03/06/2018 SUPPL-75 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/012151s075lbl.pdf
10/22/2014 SUPPL-72 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/012151s072lbl.pdf
06/12/2013 SUPPL-71 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012151s071lbl.pdf
09/17/2012 SUPPL-68 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/012151s068lbl.pdf
11/25/2008 SUPPL-62 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/012151s062lbl.pdf
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