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FDA approval · 2014-07-15

FDA Approved: BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE — Original Application (Padagis US LLC)

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Summary

FDA approved an Original Application (ANDA) for a triple-ingredient cough/cold relief product containing brompheniramine maleate, pseudoephedrine hydrochloride,…

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Diseases / indications

Drugs mentioned

  • Brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide (brompheniramine maleate; pseudoephedrine hydrochloride; dextromethorphan hydrobromide)

Snippet

ORIG AP for BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE)