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Details for New Drug Application (NDA): 202833

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NDA 202833 describes PICATO, which is a drug marketed by Leo Pharma As and is included in one NDA. It is available from one supplier. There are eleven patents protecting this drug and one Paragraph IV challenge. Additional details are available on the PICATO profile page.

The generic ingredient in PICATO is ingenol mebutate. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ingenol mebutate profile page.

Summary for NDA: 202833

Tradename:
PICATO
Applicant:
Leo Pharma As
Ingredient:
ingenol mebutate
Patents:11
Formulation / Manufacturing:see details

Pharmacology for NDA: 202833

Physiological EffectIncreased Cellular Death

Suppliers and Packaging for NDA: 202833

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PICATO
ingenol mebutate
GEL;TOPICAL 202833 NDA LEO Pharma Inc. 50222-502 50222-502-47 3 TUBE in 1 CARTON (50222-502-47) > .47 g in 1 TUBE
PICATO
ingenol mebutate
GEL;TOPICAL 202833 NDA LEO Pharma Inc. 50222-502 50222-502-91 3 TUBE in 1 CARTON (50222-502-91) > .47 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength0.015%
Approval Date:Jan 23, 2012TE:RLD:Yes
Patent:8,278,292Patent Expiration:Jul 6, 2027Product Flag?YSubstance Flag?Delist Request?
Patent:8,372,827Patent Expiration:Dec 18, 2026Product Flag?YSubstance Flag?Delist Request?
Patent:8,372,828Patent Expiration:Dec 18, 2026Product Flag?YSubstance Flag?Delist Request?


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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