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 three suppliers. 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. Thirteen 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
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	0299-3823-00	2 g in 1 TUBE (0299-3823-00)
SOOLANTRA	ivermectin	CREAM;TOPICAL	206255	NDA	Galderma Laboratories, L.P.	0299-3823	0299-3823-02	1 TUBE in 1 BLISTER PACK (0299-3823-02) > 2 g in 1 TUBE

Paragraph IV (Patent) Challenges for 206255

Tradename	Dosage	Ingredient	NDA	Submissiondate
SOOLANTRA	CREAM;TOPICAL	ivermectin	206255	2016-12-30

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	1%
Approval Date:	Dec 19, 2014	TE:	AB	RLD:	Yes
Patent:	⤷ Sign up for a Free Trial	Patent Expiration:	Mar 13, 2034	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.
Patent:	⤷ Sign up for a Free Trial	Patent Expiration:	Apr 22, 2024	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Sign up for a Free Trial	Patent Expiration:	Apr 22, 2024	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.

Expired US Patents for NDA 206255

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Galderma Labs Lp	SOOLANTRA	ivermectin	CREAM;TOPICAL	206255-001	Dec 19, 2014	⤷ Sign up for a Free Trial	⤷ Sign up for a Free Trial
Galderma Labs Lp	SOOLANTRA	ivermectin	CREAM;TOPICAL	206255-001	Dec 19, 2014	⤷ Sign up for a Free Trial	⤷ Sign up for a Free Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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