APPLICATION
ANDA088487
TYPE
ANDA
ORIGINAL APPROVAL
1984-06-15
LATEST ACTION
2021-02-16
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
HYDROXYZINE PAMOATEPrescription
HYDROXYZINE PAMOATE EQ 50MG HYDROCHLORIDE · CAPSULE · ORAL
Approval history
2021-02-16Labeling · Supplement 53 · standardAP
2021-02-16Labeling · Supplement 54 · standardAP
2015-01-24Labeling · Supplement 50 · standardAP
2007-10-09Labeling · Supplement 46AP
2003-01-03Manufacturing (CMC) · Supplement 32AP
2002-04-29Manufacturing (CMC) · Supplement 31AP
2001-11-09Labeling · Supplement 30AP
2001-11-09Labeling · Supplement 29AP
2000-02-29Manufacturing (CMC) · Supplement 28AP
1999-12-30Manufacturing (CMC) · Supplement 26AP
1999-12-21Manufacturing (CMC) · Supplement 27AP
1999-05-20Manufacturing (CMC) · Supplement 25AP
1998-12-01Manufacturing (CMC) · Supplement 24AP
1998-09-18Manufacturing (CMC) · Supplement 23AP
1998-07-09Manufacturing (CMC) · Supplement 22AP
1996-09-20Labeling · Supplement 21AP
1996-04-10Labeling · Supplement 20AP
1995-01-12Labeling · Supplement 14AP
1994-12-23Manufacturing (CMC) · Supplement 19AP
1994-10-11Manufacturing (CMC) · Supplement 18AP
1992-04-03Manufacturing (CMC) · Supplement 17AP
1992-04-03Manufacturing (CMC) · Supplement 15AP
1991-08-16Manufacturing (CMC) · Supplement 12AP
1991-08-16Manufacturing (CMC) · Supplement 13AP
1991-05-09Labeling · Supplement 11AP
1990-01-04Labeling · Supplement 10AP
1990-01-04Labeling · Supplement 60AP
1987-11-16Manufacturing (CMC) · Supplement 9AP
1987-11-16Manufacturing (CMC) · Supplement 8AP
1987-03-31Manufacturing (CMC) · Supplement 7AP
1984-09-25Manufacturing (CMC) · Supplement 2AP
1984-06-15OriginalAP
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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