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FDA ANDA · ANDA087761

HYDROXYZINE PAMOATE

Sponsor: IVAX SUB TEVA PHARMS

APPLICATION
ANDA087761
TYPE
ANDA
ORIGINAL APPROVAL
1982-03-05
LATEST ACTION
2002-07-29
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

HYDROXYZINE PAMOATEDiscontinued
HYDROXYZINE PAMOATE EQ 25MG HYDROCHLORIDE · CAPSULE · ORAL

Approval history

2002-07-29Manufacturing (CMC) · Supplement 21AP
2001-09-12Manufacturing (CMC) · Supplement 20AP
2000-11-13Manufacturing (CMC) · Supplement 19AP
2000-07-05Labeling · Supplement 18AP
2000-07-05Manufacturing (CMC) · Supplement 16AP
2000-01-28Manufacturing (CMC) · Supplement 17AP
1999-04-30Manufacturing (CMC) · Supplement 15AP
1999-04-30Manufacturing (CMC) · Supplement 13AP
1999-04-30Manufacturing (CMC) · Supplement 14AP
1998-12-09Manufacturing (CMC) · Supplement 12AP
1997-05-30Manufacturing (CMC) · Supplement 11AP
1993-07-02Labeling · Supplement 9AP
1993-07-02Manufacturing (CMC) · Supplement 8AP
1992-10-26Manufacturing (CMC) · Supplement 7AP
1992-10-16Labeling · Supplement 10AP
1992-09-01Manufacturing (CMC) · Supplement 6AP
1989-08-25Labeling · Supplement 5AP
1988-02-11Manufacturing (CMC) · Supplement 4AP
1987-09-15Manufacturing (CMC) · Supplement 2AP
1987-09-15Manufacturing (CMC) · Supplement 3AP
1987-09-15Manufacturing (CMC) · Supplement 1AP
1982-03-05OriginalAP
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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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