General MedicationsOINTMENTGeneric
CRISABOROLE
CRISABOROLE
Standard Dose
2%
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: None (Tentative Approval)
Summary
Approval overview CRISABOROLE is listed in Drugs@FDA under application 216242 (ANDA).
Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient CRISABOROLE Form and strength OINTMENT - 2% Sponsor MACLEODS PHARMS LTD Submission history Latest submission status date: 2025-06-04 00:00:00.
Structured Monograph
Clinical summary
Approval overview CRISABOROLE is listed in Drugs@FDA under application 216242 (ANDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient CRISABOROLE Form and strength OINTMENT - 2% Sponsor MACLEODS PHARMS LTD Submission history Latest submission status date: 2025-06-04 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: None (Tentative Approval)
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.