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Last Updated: September 21, 2021

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Details for New Drug Application (NDA): 202736

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NDA 202736 describes SKLICE, which is a drug marketed by Arbor Pharms Llc and is included in one NDA. It is available from one supplier. Additional details are available on the SKLICE profile page.

The generic ingredient in SKLICE is ivermectin. There are five drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the ivermectin profile page.
Summary for 202736
Applicant:Arbor Pharms Llc
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 202736
Suppliers and Packaging for NDA: 202736
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SKLICE ivermectin LOTION;TOPICAL 202736 NDA Arbor Pharmaceuticals 24338-185 24338-185-04 1 TUBE in 1 CARTON (24338-185-04) > 117 g in 1 TUBE
Paragraph IV (Patent) Challenges for 202736
Tradename Dosage Ingredient NDA Submissiondate
SKLICE LOTION;TOPICAL ivermectin 202736 2017-09-01

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:LOTION;TOPICALStrength0.5%
Approval Date:Feb 7, 2012TE:RLD:Yes

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Johnson and Johnson

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