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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 011459
Company: PFIZER

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VISTARIL HYDROXYZINE PAMOATE EQ 25MG HYDROCHLORIDE CAPSULE;ORAL Discontinued None Yes No
VISTARIL HYDROXYZINE PAMOATE EQ 50MG HYDROCHLORIDE CAPSULE;ORAL Discontinued None Yes No
VISTARIL HYDROXYZINE PAMOATE EQ 100MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE;ORAL Discontinued None Yes No

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
11/08/2016 SUPPL-51 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/011459s051_011795s028lbl.pdf
02/18/2016 SUPPL-50 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/011459s050,011795s027lbl.pdf
06/03/2014 SUPPL-48 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/011459s048,011795s025lbl.pdf
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