Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 011111
Company: PFIZER

Products on NDA 011111

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VISTARIL	HYDROXYZINE HYDROCHLORIDE	25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	INJECTABLE;INJECTION	Discontinued	None	Yes	No
VISTARIL	HYDROXYZINE HYDROCHLORIDE	50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	INJECTABLE;INJECTION	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 011111

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/18/1957	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
03/21/2001	SUPPL-33	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/11795S18LTR.PDF
06/20/1985	SUPPL-24	Labeling		Label is not available on this site.
08/27/1974	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.