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FDA NDA · NDA011111

VISTARIL

Sponsor: PFIZER

APPLICATION
NDA011111
TYPE
NDA
ORIGINAL APPROVAL
1957-09-18
LATEST ACTION
2001-03-21
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

VISTARIL · ReferenceDiscontinued
HYDROXYZINE HYDROCHLORIDE 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
VISTARIL · ReferenceDiscontinued
HYDROXYZINE HYDROCHLORIDE 25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

2001-03-21Labeling · Supplement 33 · standard — Letter ↗AP
1985-06-20Labeling · Supplement 24AP
1974-08-27Manufacturing (CMC) · Supplement 13 · standardAP
1957-09-18Type 3 - New Dosage Form · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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