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Last Updated: June 4, 2020

DrugPatentWatch Database Preview

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. There are two patents protecting this drug and one Paragraph IV challenge. 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. Seven suppliers are listed for this compound. Additional details are available on the ivermectin profile page.
Summary for 202736
Tradename:SKLICE
Applicant:Arbor Pharms Llc
Ingredient:ivermectin
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 202736
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 24338-183 24338-183-04 1 TUBE in 1 CARTON (24338-183-04) > 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:RXDosage:LOTION;TOPICALStrength0.5%
Approval Date:Feb 7, 2012TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Oct 12, 2027Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Oct 12, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:FOR HEAD LICE INFESTATIONS

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