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General MedicationsORALGeneric

DIMETANE-DX

BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

Standard Dose
2MG/5ML;10MG/5ML;30MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview DIMETANE-DX is listed in Drugs@FDA under application 019279 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE Form and strength SYRUP;ORAL - 2MG/5ML;10MG/5ML;30MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor ROBINS AH Submission history Latest submission status date: 2001-02-22 00:00:00.

Structured Monograph

Clinical summary

Approval overview DIMETANE-DX is listed in Drugs@FDA under application 019279 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE Form and strength SYRUP;ORAL - 2MG/5ML;10MG/5ML;30MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor ROBINS AH Submission history Latest submission status date: 2001-02-22 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Discontinued
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.