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General MedicationsORALStandard

DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE

DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE

Standard Dose
20MG;10MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE is listed in Drugs@FDA under application 218426 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE Form and strength CAPSULE;ORAL - 20MG;10MG Sponsor HETERO LABS LTD III Submission history Latest submission status date: 2024-08-28 00:00:00.

Structured Monograph

Clinical summary

Approval overview DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE is listed in Drugs@FDA under application 218426 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE Form and strength CAPSULE;ORAL - 20MG;10MG Sponsor HETERO LABS LTD III Submission history Latest submission status date: 2024-08-28 00:00:00. Submission type: ORIG.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.