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FDA NDA · NDA011795

VISTARIL

Sponsor: PFIZER

APPLICATION
NDA011795
TYPE
NDA
ORIGINAL APPROVAL
1959-06-03
LATEST ACTION
2016-11-08
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Discontinued

Products

VISTARIL · ReferenceDiscontinued
HYDROXYZINE PAMOATE EQ 25MG HYDROCHLORIDE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SUSPENSION · ORAL

Approval history

2016-11-08Labeling · Supplement 28 · 901 required — Letter ↗AP
2016-02-18Labeling · Supplement 27 · 901 required — Letter ↗AP
2014-06-03Labeling · Supplement 25 · standard — Letter ↗AP
2004-12-24Labeling · Supplement 20 · standard — Letter ↗AP
2001-03-21Labeling · Supplement 18 · standard — Letter ↗AP
2000-08-30Labeling · Supplement 16 · standardAP
2000-07-20Manufacturing (CMC) · Supplement 19 · standardAP
1979-05-21Labeling · Supplement 11AP
1975-06-06Manufacturing (CMC) · Supplement 6 · standardAP
1974-12-02Labeling · Supplement 5AP
1959-06-03Type 3 - New Dosage Form · Original · standardAP
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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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