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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 two suppliers. There are three patents protecting this drug. 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. Six suppliers are listed for this compound. Additional details are available on the ivermectin profile page.

Summary for NDA: 202736

Tradename:
SKLICE
Applicant:
Arbor Pharms Llc
Ingredient:
ivermectin
Patents:3
Therapeutic Class:Antiparasitics
Formulation / Manufacturing:see details

Pharmacology for NDA: 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
SKLICE
ivermectin
LOTION;TOPICAL 202736 NDA Sanofi Pasteur, Inc 49281-183 49281-183-71 1 TUBE in 1 BOX (49281-183-71) > 117 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:LOTION;TOPICALStrength0.5%
Approval Date:Feb 7, 2012TE:RLD:Yes
Patent:6,103,248Patent Expiration:May 22, 2018Product Flag?YSubstance Flag?Delist Request?
Patent:8,791,153Patent Expiration:Oct 12, 2027Product Flag?YSubstance Flag?Delist Request?
Patent:8,927,595Patent Expiration:Oct 12, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:FOR HEAD LICE INFESTATIONS


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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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