APPLICATION
ANDA087479
TYPE
ANDA
ORIGINAL APPROVAL
1981-12-14
LATEST ACTION
2021-02-16
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
HYDROXYZINE PAMOATEPrescription
HYDROXYZINE PAMOATE EQ 25MG HYDROCHLORIDE · CAPSULE · ORAL
Approval history
2021-02-16Labeling · Supplement 40 · standardAP
2021-02-16Labeling · Supplement 41 · standardAP
2015-01-24Labeling · Supplement 39 · standardAP
2013-06-27Labeling · Supplement 31 · standardAP
2002-12-20Labeling · Supplement 23AP
2000-02-02Manufacturing (CMC) · Supplement 22AP
1996-06-24Labeling · Supplement 21AP
1996-05-22Labeling · Supplement 19AP
1996-04-12Manufacturing (CMC) · Supplement 20AP
1995-03-03Manufacturing (CMC) · Supplement 16AP
1995-03-03Manufacturing (CMC) · Supplement 17AP
1994-12-12Manufacturing (CMC) · Supplement 14AP
1994-12-12Manufacturing (CMC) · Supplement 12AP
1994-12-09Manufacturing (CMC) · Supplement 18AP
1994-12-09Manufacturing (CMC) · Supplement 13AP
1992-08-12Labeling · Supplement 15AP
1989-05-09Labeling · Supplement 10AP
1986-03-07Manufacturing (CMC) · Supplement 9AP
1986-03-07Manufacturing (CMC) · Supplement 8AP
1981-12-14OriginalAP
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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