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FDA ANDA · ANDA040649
PROMETHAZINE DM
promethazine hydrochloride and dextromethorphan hydrobromide
Sponsor: PAI HOLDINGS
APPLICATION
ANDA040649
TYPE
ANDA
ORIGINAL APPROVAL
2006-02-14
LATEST ACTION
2006-02-14
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Prescription
Products
PROMETHAZINE DMPrescription
DEXTROMETHORPHAN HYDROBROMIDE 15MG/5ML, PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML · SYRUP · ORAL
Approval history
2006-02-14OriginalAP
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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