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FDA ANDA · ANDA206793
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY
Sponsor: NOVEL LABS INC
APPLICATION
ANDA206793
TYPE
ANDA
ORIGINAL APPROVAL
2016-03-08
LATEST ACTION
2016-03-08
ROUTE
ORAL
DOSAGE FORM
TABLET, CHEWABLE
MARKETING STATUS
Over-the-counter
Products
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGYOver-the-counter
CETIRIZINE HYDROCHLORIDE 10MG · TABLET, CHEWABLE · ORAL
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGYOver-the-counter
CETIRIZINE HYDROCHLORIDE 5MG · TABLET, CHEWABLE · ORAL
Approval history
2016-03-08UNKNOWN · Original · standardAP
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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