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FDA ANDA · ANDA209107

CETIRIZINE HYDROCHLORIDE (ALLERGY)

cetirizine hydrochloride

Sponsor: AUROBINDO PHARMA LTD

APPLICATION
ANDA209107
TYPE
ANDA
ORIGINAL APPROVAL
2018-07-20
LATEST ACTION
2018-07-20
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Over-the-counter

Products

CETIRIZINE HYDROCHLORIDE ALLERGYOver-the-counter
CETIRIZINE HYDROCHLORIDE 10MG · CAPSULE · ORAL
CETIRIZINE HYDROCHLORIDE HIVES RELIEFOver-the-counter
CETIRIZINE HYDROCHLORIDE 10MG · CAPSULE · ORAL

Approval history

2018-07-20UNKNOWN · Original · standardLetterAP
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