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Deloitte
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Generated: June 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206255

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NDA 206255 describes SOOLANTRA, which is a drug marketed by Galderma Labs Lp and is included in one NDA. It is available from one supplier. There are twelve patents protecting this drug and one Paragraph IV challenge. Additional details are available on the SOOLANTRA profile page.

The generic ingredient in SOOLANTRA is ivermectin. There are five drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the ivermectin profile page.
Summary for 206255
Tradename:SOOLANTRA
Applicant:Galderma Labs Lp
Ingredient:ivermectin
Patents:12
Therapeutic Class:Antiparasitics
Formulation / Manufacturing:see details
Pharmacology for NDA: 206255
Medical Subject Heading (MeSH) Categories for 206255
Antiparasitic Agents
Insecticides
Suppliers and Packaging for NDA: 206255
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SOOLANTRA ivermectin CREAM;TOPICAL 206255 NDA Galderma Laboratories, L.P. 0299-3823 N 0299-3823-02
SOOLANTRA ivermectin CREAM;TOPICAL 206255 NDA Galderma Laboratories, L.P. 0299-3823 N 0299-3823-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength1%
Approval Date:Dec 19, 2014TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Sep 18, 2018Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.
Patent:➤ Sign UpPatent Expiration:Apr 26, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.
Patent:➤ Sign UpPatent Expiration:Apr 22, 2024Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.

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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
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Argus Health
Deloitte
Cantor Fitzgerald
Farmers Insurance
Express Scripts
McKesson

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