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FDA ANDA · ANDA040604

HYDROXYZINE HYDROCHLORIDE

Sponsor: EPIC PHARMA LLC

APPLICATION
ANDA040604
TYPE
ANDA
ORIGINAL APPROVAL
2004-12-28
LATEST ACTION
2016-11-08
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

2016-11-08Labeling · Supplement 8 · standardAP
2016-03-30Labeling · Supplement 6 · standardAP
2015-04-06Labeling · Supplement 3 · standardAP
2004-12-28Original — Other ↗AP
VIEW ON DRUGS@FDA ↗

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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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