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FDA approval · 2020-09-30

FDA Approved: BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE — Original Application (BIONPHARMA INC.)

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Summary

FDA approved Bionpharma's original ANDA for a three-drug cough/cold product containing brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorp…

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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)