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General MedicationsORALStandard

LOMOTIL

ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE

Standard Dose
0.025MG;2.5MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview LOMOTIL is listed in Drugs@FDA under application 012462 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE Form and strength TABLET;ORAL - 0.025MG;2.5MG Sponsor PFIZER Submission history Latest submission status date: 2018-02-12 00:00:00.

Structured Monograph

Clinical summary

Approval overview LOMOTIL is listed in Drugs@FDA under application 012462 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE Form and strength TABLET;ORAL - 0.025MG;2.5MG Sponsor PFIZER Submission history Latest submission status date: 2018-02-12 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.
LOMOTIL (ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE) | Drug Monograph | MedicHelpline