APPLICATION
ANDA087871
TYPE
ANDA
ORIGINAL APPROVAL
1982-12-20
LATEST ACTION
2016-11-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
HYDROXYZINE HYDROCHLORIDEPrescription
HYDROXYZINE HYDROCHLORIDE 10MG · TABLET · ORAL
HYDROXYZINE HYDROCHLORIDEPrescription
HYDROXYZINE HYDROCHLORIDE 25MG · TABLET · ORAL
HYDROXYZINE HYDROCHLORIDEPrescription
HYDROXYZINE HYDROCHLORIDE 50MG · TABLET · ORAL
Approval history
2016-11-08Labeling · Supplement 28 · standardAP
2016-03-30Labeling · Supplement 27 · standardAP
2014-06-03Labeling · Supplement 26 · standardAP
2000-01-10Manufacturing (CMC) · Supplement 22AP
1995-02-21Manufacturing (CMC) · Supplement 21AP
1988-11-14Labeling · Supplement 20AP
1988-04-25Manufacturing (CMC) · Supplement 14AP
1988-04-25Manufacturing (CMC) · Supplement 15AP
1985-07-08Manufacturing (CMC) · Supplement 8AP
1985-07-08Manufacturing (CMC) · Supplement 5AP
1984-08-21Manufacturing (CMC) · Supplement 4AP
1984-08-21Manufacturing (CMC) · Supplement 2AP
1984-08-21Manufacturing (CMC) · Supplement 1AP
1982-12-20OriginalAP
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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