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Generated: November 12, 2018

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Details for New Drug Application (NDA): 210361

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NDA 210361 describes QBREXZA, which is a drug marketed by Dermira Inc and is included in one NDA. It is available from one supplier. There are eight patents protecting this drug. Additional details are available on the QBREXZA profile page.

The generic ingredient in QBREXZA is glycopyrronium tosylate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the glycopyrronium tosylate profile page.
Summary for 210361
Tradename:QBREXZA
Applicant:Dermira Inc
Ingredient:glycopyrronium tosylate
Patents:8
Generic Entry Opportunity Date for 210361
Generic Entry Date for 210361*:
Constraining patent/regulatory exclusivity:
Dosage:
CLOTH;TOPICAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 210361
Mechanism of ActionCholinergic Antagonists
Suppliers and Packaging for NDA: 210361
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
QBREXZA glycopyrronium tosylate CLOTH;TOPICAL 210361 NDA Dermira, Inc. 70428-011 70428-011-12 30 POUCH in 1 CARTON (70428-011-12) > 2.8 g in 1 POUCH (70428-011-11)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CLOTH;TOPICALStrengthEQ 2.4% BASE
Approval Date:Jun 28, 2018TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Feb 28, 2033Product Flag?YSubstance Flag?Delist Request?
Patented Use:TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER
Patent:➤ Sign UpPatent Expiration:Oct 17, 2028Product Flag?YSubstance Flag?Delist Request?
Patented Use:TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER
Patent:➤ Sign UpPatent Expiration:Apr 10, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER

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