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General MedicationsORAL, RECTALGeneric

CEPHULAC

LACTULOSE

Standard Dose
10GM/15ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: PRIORITY Marketing status: Discontinued
Summary

Approval overview CEPHULAC is listed in Drugs@FDA under application 017657 (NDA).

Review priority: PRIORITY Marketing status: Discontinued Active ingredient LACTULOSE Form and strength SOLUTION;ORAL, RECTAL - 10GM/15ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor SANOFI AVENTIS US Submission history Latest submission status date: 1993-02-09 00:00:00.

Structured Monograph

Clinical summary

Approval overview CEPHULAC is listed in Drugs@FDA under application 017657 (NDA). Review priority: PRIORITY Marketing status: Discontinued Active ingredient LACTULOSE Form and strength SOLUTION;ORAL, RECTAL - 10GM/15ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor SANOFI AVENTIS US Submission history Latest submission status date: 1993-02-09 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Discontinued
  • • Review priority: PRIORITY

Interaction Notes

  • No interaction notes stored yet.
CEPHULAC (LACTULOSE) | Drug Monograph | MedicHelpline