FDA
Ingenol Mebutate
The FDA lists this product in 3 strengths and forms.
Composition
- Active ingredients
- INGENOL MEBUTATE 0.05%
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- INGENOL MEBUTATE 0.05% · GelThis page
- INGENOL MEBUTATE 0.05% · GelANDA209019-001 · Discontinued
- INGENOL MEBUTATE 0.015% · GelANDA209018-001 · Discontinued
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA209086.
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.
At a glance
- Brand name
- Ingenol Mebutate
- Route
- Topical
- Dosage form
- Gel
- Applicant
- Actavis Labs
- Status
- Tentative approval
- FDA approval
- 6 Feb 2018
- Application
- ANDA209086-001