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FDA ANDA · ANDA040010

HYDROXYZINE HYDROCHLORIDE

Sponsor: HIKMA

APPLICATION
ANDA040010
TYPE
ANDA
ORIGINAL APPROVAL
1994-10-28
LATEST ACTION
2016-11-08
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Discontinued

Products

HYDROXYZINE HYDROCHLORIDEDiscontinued
HYDROXYZINE HYDROCHLORIDE 10MG/5ML · SYRUP · ORAL

Approval history

2016-11-08Labeling · Supplement 12 · standardAP
2016-03-30Labeling · Supplement 11 · standardAP
2014-06-03Labeling · Supplement 8 · standard — Label ↗AP
2000-08-01Manufacturing (CMC) · Supplement 2AP
2000-08-01Labeling · Supplement 3AP
1994-10-28OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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