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FDA NDA · NDA011459

VISTARIL

Sponsor: PFIZER

APPLICATION
NDA011459
TYPE
NDA
ORIGINAL APPROVAL
1968-11-15
LATEST ACTION
2016-11-08
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued, Prescription

Products

VISTARIL · ReferenceDiscontinued
HYDROXYZINE PAMOATE EQ 100MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
VISTARIL · ReferencePrescription
HYDROXYZINE PAMOATE EQ 50MG HYDROCHLORIDE · CAPSULE · ORAL
VISTARIL · ReferencePrescription
HYDROXYZINE PAMOATE EQ 25MG HYDROCHLORIDE · CAPSULE · ORAL

Approval history

2016-11-08Labeling · Supplement 51 · 901 required — Letter ↗AP
2016-02-18Labeling · Supplement 50 · 901 required — Label ↗AP
2014-06-03Labeling · Supplement 48 · standard — Letter ↗AP
2004-12-24Labeling · Supplement 39 · standard — Letter ↗AP
2001-03-21Labeling · Supplement 36 · standard — Letter ↗AP
2000-08-30Labeling · Supplement 35 · standardAP
2000-06-13Manufacturing (CMC) · Supplement 38 · standardAP
2000-03-27Manufacturing (CMC) · Supplement 37 · standardAP
1994-11-28Manufacturing (CMC) · Supplement 34 · standardAP
1979-05-21Labeling · Supplement 23AP
1974-12-02Manufacturing (CMC) · Supplement 11 · standardAP
1968-11-15Type 2 - New Active Ingredient · 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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