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FDA NDA · NDA010485

ATARAX

Sponsor: ROERIG

APPLICATION
NDA010485
TYPE
NDA
ORIGINAL APPROVAL
1956-05-31
LATEST ACTION
2001-03-21
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Discontinued

Products

ATARAXDiscontinued
HYDROXYZINE HYDROCHLORIDE 10MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SYRUP · ORAL

Approval history

2001-03-21Labeling · Supplement 18 · standard — Letter ↗AP
1985-05-20Labeling · Supplement 16AP
1979-05-21Labeling · Supplement 11AP
1956-05-31Type 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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