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General MedicationsTRANSDERMALGeneric

FENTANYL-100

FENTANYL

Standard Dose
100MCG/HR
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview FENTANYL-100 is listed in Drugs@FDA under application 209655 (ANDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient FENTANYL Form and strength FILM, EXTENDED RELEASE;TRANSDERMAL - 100MCG/HR Sponsor ZYDUS PHARMS Submission history Latest submission status date: 2025-12-22 00:00:00.

Structured Monograph

Clinical summary

Approval overview FENTANYL-100 is listed in Drugs@FDA under application 209655 (ANDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient FENTANYL Form and strength FILM, EXTENDED RELEASE;TRANSDERMAL - 100MCG/HR Sponsor ZYDUS PHARMS Submission history Latest submission status date: 2025-12-22 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.