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General MedicationsORALGeneric

MOTOFEN HALF-STRENGTH

ATROPINE SULFATE; DIFENOXIN HYDROCHLORIDE

Standard Dose
0.025MG;0.5MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview MOTOFEN HALF-STRENGTH is listed in Drugs@FDA under application 017744 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient ATROPINE SULFATE; DIFENOXIN HYDROCHLORIDE Form and strength TABLET;ORAL - 0.025MG;0.5MG Sponsor LEGACY PHARMA Submission history Latest submission status date: 2017-03-28 00:00:00.

Structured Monograph

Clinical summary

Approval overview MOTOFEN HALF-STRENGTH is listed in Drugs@FDA under application 017744 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient ATROPINE SULFATE; DIFENOXIN HYDROCHLORIDE Form and strength TABLET;ORAL - 0.025MG;0.5MG Sponsor LEGACY PHARMA Submission history Latest submission status date: 2017-03-28 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.