FDA NDA · NDA010392
ATARAX
Sponsor: PFIZER
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APPLICATION
NDA010392
TYPE
NDA
ORIGINAL APPROVAL
1956-04-12
LATEST ACTION
2001-03-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ATARAX · ReferenceDiscontinued
HYDROXYZINE HYDROCHLORIDE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
ATARAX · ReferenceDiscontinued
HYDROXYZINE HYDROCHLORIDE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
ATARAX · ReferenceDiscontinued
HYDROXYZINE HYDROCHLORIDE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
ATARAX · ReferenceDiscontinued
HYDROXYZINE HYDROCHLORIDE 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2000-03-27Manufacturing (CMC) · Supplement 40 · standardAP
1998-01-16Manufacturing (CMC) · Supplement 38 · standardAP
1998-01-16Manufacturing (CMC) · Supplement 36 · standardAP
1994-07-12Manufacturing (CMC) · Supplement 37 · standardAP
1985-05-20Labeling · Supplement 31AP
1979-05-21Labeling · Supplement 21AP
1974-12-02Labeling · Supplement 8AP
1956-04-12Type 1 - New Molecular Entity · Original · standardAP
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