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FDA ANDA · ANDA091687

PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE

Sponsor: COSETTE PHARMS NC

APPLICATION
ANDA091687
TYPE
ANDA
ORIGINAL APPROVAL
2012-06-28
LATEST ACTION
2012-06-28
ROUTE
ORAL
DOSAGE FORM
SYRUP, TABLET, CHEWABLE, TABLET, CAPSULE
MARKETING STATUS
Prescription

Products

PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEPrescription
DEXTROMETHORPHAN HYDROBROMIDE 15MG/5ML, PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML · SYRUP · ORAL
PROMETHAZINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDEPrescription
PROMETHAZINE HYDROCHLORIDE 15MG/5ML, DEXTROMETHORPHAN HYDROBROMIDE · TABLET, CHEWABLE, TABLET, CAPSULE · ORAL

Approval history

2012-06-28Not Applicable · OriginalAP
VIEW ON DRUGS@FDA ↗

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