FDA ANDA · ANDA087857

HYDROXYZINE HYDROCHLORIDE

Sponsor: MUTUAL PHARM

APPLICATION

ANDA087857

TYPE

ANDA

ORIGINAL APPROVAL

1983-04-18

LATEST ACTION

1998-12-01

ROUTE

ORAL

DOSAGE FORM

TABLET

MARKETING STATUS

Discontinued

Products

HYDROXYZINE HYDROCHLORIDEDiscontinued

HYDROXYZINE HYDROCHLORIDE 25MG · TABLET · ORAL

1998-12-01Manufacturing (CMC) · Supplement 14AP

1994-12-23Manufacturing (CMC) · Supplement 13AP

1994-10-11Manufacturing (CMC) · Supplement 12AP

1992-04-03Manufacturing (CMC) · Supplement 11AP

1992-04-03Manufacturing (CMC) · Supplement 9AP

1987-12-10Manufacturing (CMC) · Supplement 7AP

1987-12-10Manufacturing (CMC) · Supplement 6AP

1987-04-01Manufacturing (CMC) · Supplement 4AP

1984-11-20Manufacturing (CMC) · Supplement 2AP

1983-04-18OriginalAP

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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