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

Summary for NDA: 206255

Tradename:
SOOLANTRA
Applicant:
Galderma Labs Lp
Ingredient:
ivermectin
Patents:11
Therapeutic Class:Antiparasitics
Formulation / Manufacturing:see details

Pharmacology for NDA: 206255

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 0299-3823-30 1 TUBE in 1 CARTON (0299-3823-30) > 30 g in 1 TUBE
SOOLANTRA
ivermectin
CREAM;TOPICAL 206255 NDA Galderma Laboratories, L.P. 0299-3823 0299-3823-45 1 TUBE in 1 CARTON (0299-3823-45) > 45 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength1%
Approval Date:Dec 19, 2014TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 19, 2017
Regulatory Exclusivity Use:NEW PRODUCT
Patent:5,952,372Patent Expiration:Sep 18, 2018Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.
Patent:6,133,310Patent Expiration:Apr 26, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.


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