Details for New Drug Application (NDA): 202833
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The generic ingredient in PICATO 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 202833
Tradename: | PICATO |
Applicant: | Leo Labs |
Ingredient: | ingenol mebutate |
Patents: | 12 |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | GEL;TOPICAL | Strength | 0.015% | ||||
Approval Date: | Jan 23, 2012 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jul 6, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Dec 18, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Dec 18, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? |
Expired US Patents for NDA 202833
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Leo Labs | PICATO | ingenol mebutate | GEL;TOPICAL | 202833-002 | Jan 23, 2012 | ⤷ Sign Up | ⤷ Sign Up |
Leo Labs | PICATO | ingenol mebutate | GEL;TOPICAL | 202833-002 | Jan 23, 2012 | ⤷ Sign Up | ⤷ Sign Up |
Leo Labs | PICATO | ingenol mebutate | GEL;TOPICAL | 202833-001 | Jan 23, 2012 | ⤷ Sign Up | ⤷ Sign Up |
Leo Labs | PICATO | ingenol mebutate | GEL;TOPICAL | 202833-001 | Jan 23, 2012 | ⤷ Sign Up | ⤷ Sign Up |
Leo Labs | PICATO | ingenol mebutate | GEL;TOPICAL | 202833-002 | Jan 23, 2012 | ⤷ Sign Up | ⤷ Sign Up |
Leo Labs | PICATO | ingenol mebutate | GEL;TOPICAL | 202833-002 | Jan 23, 2012 | ⤷ Sign Up | ⤷ Sign Up |
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