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General MedicationsORALGeneric

ACCUTANE

ISOTRETINOIN

Standard Dose
20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 ACCUTANE is listed in Drugs@FDA under application 018662 (NDA).

Review priority: PRIORITY Marketing status: Discontinued Active ingredient ISOTRETINOIN Form and strength CAPSULE;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor HOFFMANN LA ROCHE Submission history Latest submission status date: 2010-10-22 00:00:00.

Structured Monograph

Clinical summary

Approval overview ACCUTANE is listed in Drugs@FDA under application 018662 (NDA). Review priority: PRIORITY Marketing status: Discontinued Active ingredient ISOTRETINOIN Form and strength CAPSULE;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor HOFFMANN LA ROCHE Submission history Latest submission status date: 2010-10-22 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.