FDA Drug Application (019279) for DIMETANE-DX by ROBINS AH

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Application Number019279
Product Number001
FormSYRUP;ORAL
Dosage2MG/5ML;10MG/5ML;30MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Product Market Status Discontinued
Therapeutic Equivalence Evaluation Code
Reference Drug
Drug NameDIMETANE-DX
Active IngredientBROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE



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