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FDA ANDA · ANDA204226

CHILDRENS CETIRIZINE HYDROCHLORIDE

cetirizine hcl

Sponsor: PERRIGO R AND D

APPLICATION
ANDA204226
TYPE
ANDA
ORIGINAL APPROVAL
2013-09-09
LATEST ACTION
2015-04-15
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Over-the-counter

Products

CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGYOver-the-counter
CETIRIZINE HYDROCHLORIDE 5MG/5ML · SOLUTION · ORAL

Approval history

2015-04-15Labeling · Supplement 5 · standardAP
2013-09-09UNKNOWN · OriginalAP
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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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