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FDA ANDA · ANDA087821

HYDROXYZINE HYDROCHLORIDE

Sponsor: KV PHARM

APPLICATION
ANDA087821
TYPE
ANDA
ORIGINAL APPROVAL
1982-06-23
LATEST ACTION
1989-07-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

HYDROXYZINE HYDROCHLORIDEDiscontinued
HYDROXYZINE HYDROCHLORIDE 50MG · TABLET · ORAL

Approval history

1989-07-11Labeling · Supplement 12AP
1988-09-02Labeling · Supplement 11AP
1988-04-05Labeling · Supplement 10AP
1982-06-23OriginalAP
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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