Details for New Drug Application (NDA): 209019
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The generic ingredient in INGENOL MEBUTATE is ingenol mebutate. There are three drug master file entries for this compound. Additional details are available on the ingenol mebutate profile page.
Summary for 209019
Tradename: | INGENOL MEBUTATE |
Applicant: | Padagis Israel |
Ingredient: | ingenol mebutate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | GEL;TOPICAL | Strength | 0.05% | ||||
Approval Date: | Jan 9, 2019 | TE: | RLD: | No |
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