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FDA ANDA · ANDA211170
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE,
Sponsor: HIBROW HLTHCARE
APPLICATION
ANDA211170
TYPE
ANDA
ORIGINAL APPROVAL
2020-06-16
LATEST ACTION
2020-06-16
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Prescription
Products
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEPrescription
BROMPHENIRAMINE MALEATE 2MG/5ML, DEXTROMETHORPHAN HYDROBROMIDE 10MG/5ML, PSEUDOEPHEDRINE HYDROCHLORIDE 30MG/5ML · SYRUP · ORAL
Approval history
2020-06-16UNKNOWN · Original · standardAP
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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