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FDA NDA · NDA020346

ZYRTEC

Sponsor: J AND J CONSUMER INC

APPLICATION
NDA020346
TYPE
NDA
ORIGINAL APPROVAL
1996-09-27
LATEST ACTION
2004-03-17
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

ZYRTEC · ReferenceDiscontinued
CETIRIZINE HYDROCHLORIDE 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · ORAL

Approval history

2004-03-17Labeling · Supplement 11 · standard — Review ↗AP
2002-10-21Efficacy · Supplement 8 · standard — Review ↗AP
2002-07-19Manufacturing (CMC) · Supplement 9 · standardAP
2000-02-25Labeling · Supplement 6 · standardAP
1999-03-04Manufacturing (CMC) · Supplement 5 · standardAP
1998-06-10Manufacturing (CMC) · Supplement 4 · standardAP
1998-05-15Efficacy · Supplement 2 · standard — Review ↗AP
1997-10-21Manufacturing (CMC) · Supplement 3 · standardAP
1997-04-18Manufacturing (CMC) · Supplement 1 · standardAP
1996-09-27Type 3 - New Dosage Form · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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