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Generated: November 13, 2018

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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 eleven 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. Eight 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:11
Pharmacology for NDA: 204708
Mechanism of ActionAdrenergic alpha-Agonists
Medical Subject Heading (MeSH) Categories for 204708
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:RXDosage:GEL;TOPICALStrengthEQ 0.33% BASE
Approval Date:Aug 23, 2013TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Aug 25, 2025Product Flag?Substance Flag?Delist Request?
Patented Use:TOPICAL TREATMENT OF FACIAL ERYTHEMA OF ROSACEA
Patent:➤ Try a Free TrialPatent Expiration:Jun 13, 2031Product Flag?YSubstance Flag?Delist Request?
Patented Use:TOPICAL TREATMENT OF FACIAL ERYTHEMA OF ROSACEA
Patent:➤ Try a Free TrialPatent Expiration:Jun 13, 2031Product Flag?YSubstance Flag?Delist Request?

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