Details for New Drug Application (NDA): 204708

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NDA 204708 describes MIRVASO, 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 MIRVASO profile page.

The generic ingredient in MIRVASO is brimonidine tartrate. There are eleven drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the brimonidine tartrate profile page.

Summary for 204708

Tradename:	MIRVASO
Applicant:	Galderma Labs Lp
Ingredient:	brimonidine tartrate
Patents:	12

Pharmacology for NDA: 204708

Mechanism of Action	Adrenergic alpha-Agonists

Medical Subject Heading (MeSH) Categories for 204708

Adrenergic alpha-2 Receptor Agonists
Antihypertensive Agents

Suppliers and Packaging for NDA: 204708

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MIRVASO	brimonidine tartrate	GEL;TOPICAL	204708	NDA	Galderma Laboratories, L.P.	0299-5980	0299-5980-00	1 TUBE in 1 BLISTER PACK (0299-5980-00) / 2 g in 1 TUBE
MIRVASO	brimonidine tartrate	GEL;TOPICAL	204708	NDA	Galderma Laboratories, L.P.	0299-5980	0299-5980-02	2 g in 1 TUBE (0299-5980-02)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;TOPICAL			Strength	EQ 0.33% BASE
Approval Date:	Aug 23, 2013	TE:	AB	RLD:	Yes
Patent:	10,201,517	Patent Expiration:	Jun 13, 2031	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	7,439,241	Patent Expiration:	Aug 25, 2025	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TOPICAL TREATMENT OF FACIAL ERYTHEMA OF ROSACEA
Patent:	8,053,427	Patent Expiration:	Jun 13, 2031	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TOPICAL TREATMENT OF FACIAL ERYTHEMA OF ROSACEA

Expired US Patents for NDA 204708

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Galderma Labs Lp	MIRVASO	brimonidine tartrate	GEL;TOPICAL	204708-001	Aug 23, 2013	8,859,551	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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