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FDA ANDA · ANDA201507

HYDROXYZINE PAMOATE

Sponsor: HERITAGE PHARMA

APPLICATION
ANDA201507
TYPE
ANDA
ORIGINAL APPROVAL
2013-06-03
LATEST ACTION
2015-01-24
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

HYDROXYZINE PAMOATEPrescription
HYDROXYZINE PAMOATE EQ 25MG HYDROCHLORIDE · CAPSULE · ORAL
HYDROXYZINE PAMOATEPrescription
HYDROXYZINE PAMOATE EQ 50MG HYDROCHLORIDE · CAPSULE · ORAL

Approval history

2015-01-24Labeling · Supplement 3 · standardAP
2013-07-11Manufacturing (CMC) · Supplement 1 · unknownAP
2013-06-03Not Applicable · OriginalAP
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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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