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FDA ANDA · ANDA205490

CETIRIZINE HYDROCHLORIDE ALLERGY

Sponsor: PERRIGO R AND D

APPLICATION
ANDA205490
TYPE
ANDA
ORIGINAL APPROVAL
2015-09-02
LATEST ACTION
2016-01-28
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Over-the-counter

Products

CETIRIZINE HYDROCHLORIDE ALLERGYOver-the-counter
CETIRIZINE HYDROCHLORIDE 10MG · TABLET, ORALLY DISINTEGRATING · ORAL

Approval history

2016-01-28Manufacturing (CMC) · Supplement 1 · unknownAP
2015-09-02UNKNOWN · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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