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FDA ANDA · ANDA087294

HYDROXYZINE HYDROCHLORIDE

Sponsor: CHARTWELL RX

APPLICATION
ANDA087294
TYPE
ANDA
ORIGINAL APPROVAL
1982-04-12
LATEST ACTION
2016-11-08
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Prescription

Products

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

Approval history

2016-11-08Labeling · Supplement 28 · standard — Letter ↗AP
2016-03-30Labeling · Supplement 27 · standardAP
2014-06-03Labeling · Supplement 26 · standard — Label ↗AP
2005-04-04Labeling · Supplement 23AP
2003-06-13Labeling · Supplement 21AP
2002-08-22Labeling · Supplement 20AP
1993-12-27Labeling · Supplement 19AP
1993-09-08Manufacturing (CMC) · Supplement 14AP
1991-02-11Labeling · Supplement 18AP
1991-02-11Labeling · Supplement 16AP
1991-02-11Labeling · Supplement 17AP
1990-06-19Labeling · Supplement 15AP
1989-06-20Labeling · Supplement 13AP
1989-02-07Manufacturing (CMC) · Supplement 12AP
1988-12-09Manufacturing (CMC) · Supplement 11AP
1987-04-07Manufacturing (CMC) · Supplement 10AP
1985-10-22Manufacturing (CMC) · Supplement 7AP
1984-12-13Manufacturing (CMC) · Supplement 5AP
1984-12-13Manufacturing (CMC) · Supplement 6AP
1984-03-16Manufacturing (CMC) · Supplement 3AP
1982-04-12OriginalAP
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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