General MedicationsTOPICALGeneric

INGENOL MEBUTATE

Standard Dose

0.05%

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: None (Tentative Approval)

Summary

Approval overview INGENOL MEBUTATE is listed in Drugs@FDA under application 209086 (ANDA).

Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient INGENOL MEBUTATE Form and strength GEL; TOPICAL - 0.05% Sponsor ACTAVIS LABS Submission history Latest submission status date: 2018-02-06 00:00:00.

Structured Monograph

Clinical summary

Approval overview INGENOL MEBUTATE is listed in Drugs@FDA under application 209086 (ANDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient INGENOL MEBUTATE Form and strength GEL; TOPICAL - 0.05% Sponsor ACTAVIS LABS Submission history Latest submission status date: 2018-02-06 00:00:00. Submission type: ORIG.

Monitoring

• Marketing status: None (Tentative Approval)
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.