Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 202833

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PICATO (INGENOL MEBUTATE)
0.015% Marketing Status: Prescription

Active Ingredient: INGENOL MEBUTATE
Proprietary Name: PICATO
Dosage Form; Route of Administration: GEL; TOPICAL
Strength: 0.015%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N202833
Product Number: 001
Approval Date: Jan 23, 2012
Applicant Holder Full Name: LEO LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

PICATO (INGENOL MEBUTATE)
0.05% Marketing Status: Prescription

Active Ingredient: INGENOL MEBUTATE
Proprietary Name: PICATO
Dosage Form; Route of Administration: GEL; TOPICAL
Strength: 0.05%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N202833
Product Number: 002
Approval Date: Jan 23, 2012
Applicant Holder Full Name: LEO LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

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