APPLICATION
ANDA040156
TYPE
ANDA
ORIGINAL APPROVAL
1996-07-15
LATEST ACTION
2023-09-19
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
HYDROXYZINE PAMOATEPrescription
HYDROXYZINE PAMOATE EQ 25MG HYDROCHLORIDE · CAPSULE · ORAL
HYDROXYZINE PAMOATEPrescription
HYDROXYZINE PAMOATE EQ 50MG HYDROCHLORIDE · CAPSULE · ORAL
Approval history
2023-09-19Labeling · Supplement 9 · standardAP
2012-10-11Labeling · Supplement 8 · standardAP
1998-07-27Manufacturing (CMC) · Supplement 4AP
1997-08-06Manufacturing (CMC) · Supplement 2AP
1997-08-06Manufacturing (CMC) · Supplement 3AP
1997-01-31Manufacturing (CMC) · Supplement 1AP
1996-07-15OriginalAP
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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