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FDA ANDA · ANDA040805

HYDROXYZINE HYDROCHLORIDE

Sponsor: HETERO LABS LTD III

APPLICATION
ANDA040805
TYPE
ANDA
ORIGINAL APPROVAL
2008-05-29
LATEST ACTION
2017-09-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

HYDROXYZINE HYDROCHLORIDEPrescription
HYDROXYZINE HYDROCHLORIDE 25MG · TABLET · ORAL
HYDROXYZINE HYDROCHLORIDEPrescription
HYDROXYZINE HYDROCHLORIDE 50MG · TABLET · ORAL
HYDROXYZINE HYDROCHLORIDEPrescription
HYDROXYZINE HYDROCHLORIDE 10MG · TABLET · ORAL

Approval history

2017-09-26Labeling · Supplement 3 · standardAP
2016-03-30Labeling · Supplement 2 · standardAP
2014-09-25Labeling · Supplement 1 · standardAP
2008-05-29Original — Other ↗AP
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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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