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FDA ANDA · ANDA091130
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY
Sponsor: CHARTWELL MOLECULAR
APPLICATION
ANDA091130
TYPE
ANDA
ORIGINAL APPROVAL
2011-04-22
LATEST ACTION
2014-01-29
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Over-the-counter
Products
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGYOver-the-counter
CETIRIZINE HYDROCHLORIDE 5MG/5ML · SOLUTION · ORAL
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEFOver-the-counter
CETIRIZINE HYDROCHLORIDE 5MG/5ML · SOLUTION · ORAL
Approval history
2014-01-29Manufacturing (CMC) · Supplement 1AP
2011-04-22OriginalAP
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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