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Last Updated: June 10, 2023

Details for New Drug Application (NDA): 207695

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NDA 207695 describes EUCRISA, which is a drug marketed by Anacor Pharms Inc and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the EUCRISA profile page.

The generic ingredient in EUCRISA is crisaborole. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the crisaborole profile page.
Summary for 207695
Applicant:Anacor Pharms Inc
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 207695
Generic Entry Date for 207695*:
Constraining patent/regulatory exclusivity:

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 207695
Mechanism of ActionPhosphodiesterase 4 Inhibitors
Suppliers and Packaging for NDA: 207695
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EUCRISA crisaborole OINTMENT;TOPICAL 207695 NDA Pfizer Laboratories Div Pfizer Inc 55724-211 55724-211-11 1 TUBE in 1 CARTON (55724-211-11) / 100 g in 1 TUBE
EUCRISA crisaborole OINTMENT;TOPICAL 207695 NDA Pfizer Laboratories Div Pfizer Inc 55724-211 55724-211-21 1 TUBE in 1 CARTON (55724-211-21) / 60 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;TOPICALStrength2%
Approval Date:Dec 14, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:Mar 23, 2023
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:Jun 14, 2022
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Regulatory Exclusivity Expiration:Sep 23, 2023
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY

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