Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 011795
Company: PFIZER
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VISTARIL HYDROXYZINE PAMOATE EQ 25MG HYDROCHLORIDE/5ML SUSPENSION;ORAL Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/03/1959 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/08/2016 SUPPL-28 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/011459s051_011795s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/011459Orig1s051,011795Orig1s028ltr.pdf
02/18/2016 SUPPL-27 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/011459s050,011795s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/011459Orig1s050,011795Orig1s027ltr.pdf
06/03/2014 SUPPL-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/011459s048,011795s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/011459Orig1s048,011795Orig1s025ltr.pdf
12/24/2004 SUPPL-20 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/11459s039,11795s020ltr.pdf
07/20/2000 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

03/21/2001 SUPPL-18 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/11795S18LTR.PDF
08/30/2000 SUPPL-16 Labeling

Label is not available on this site.

05/21/1979 SUPPL-11 Labeling

Label is not available on this site.

06/06/1975 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

12/02/1974 SUPPL-5 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/08/2016 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/011459s051_011795s028lbl.pdf
02/18/2016 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/011459s050,011795s027lbl.pdf
06/03/2014 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/011459s048,011795s025lbl.pdf

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