Details for New Drug Application (NDA): 206255

✉ Email this page to a colleague

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. Twenty 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

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

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	Patent Expiration:	Mar 13, 2034	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.
Patent:	⤷ Sign Up	Patent Expiration:	Apr 22, 2024	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Sign Up	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

Subscribe to access the full database, or Sign Up
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	⤷ Sign Up
Galderma Labs Lp	SOOLANTRA	ivermectin	CREAM;TOPICAL	206255-001	Dec 19, 2014	⤷ Sign Up	⤷ Sign Up
Galderma Labs Lp	SOOLANTRA	ivermectin	CREAM;TOPICAL	206255-001	Dec 19, 2014	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

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 verification 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.