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FDA ANDA · ANDA090750
CHILDRENS ALLERGY RELIEF
cetirizine hydrochloride
Sponsor: AUROBINDO PHARMA
APPLICATION
ANDA090750
TYPE
ANDA
ORIGINAL APPROVAL
2010-02-02
LATEST ACTION
2015-06-24
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
2015-06-24Manufacturing (CMC) · Supplement 3 · unknownAP
2010-02-02OriginalAP
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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