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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 012616
Company: PFIZER

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALDACTAZIDE HYDROCHLOROTHIAZIDE; SPIRONOLACTONE 25MG;25MG TABLET;ORAL Prescription AB Yes No
ALDACTAZIDE HYDROCHLOROTHIAZIDE; SPIRONOLACTONE 50MG;50MG TABLET;ORAL Discontinued None Yes No

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
11/14/2025 SUPPL-85 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/012616s085lbl.pdf
12/19/2022 SUPPL-83 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/012616s083lbl.pdf
02/19/2021 SUPPL-81 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/012616s081lbl.pdf
08/20/2020 SUPPL-80 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/012616s080lbl.pdf
01/17/2019 SUPPL-78 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/012616s078lbl.pdf
10/22/2014 SUPPL-76 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/012616s076lbl.pdf
03/06/2014 SUPPL-75 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/012616s075lbl.pdf
01/17/2014 SUPPL-74 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/012616s074lbl.pdf
06/12/2013 SUPPL-73 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012616s073lbl.pdf
05/19/2011 SUPPL-68 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/012616s068lbl.pdf
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