Details for New Drug Application (NDA): 210361
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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: | Journey |
| Ingredient: | glycopyrronium tosylate |
| Patents: | 8 |
Pharmacology for NDA: 210361
| Mechanism of Action | Cholinergic Antagonists Cholinergic Muscarinic 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 | Journey Medical Corporation | 69489-411 | 69489-411-05 | 5 POUCH in 1 CARTON (69489-411-05) / 2.8 g in 1 POUCH (69489-411-51) |
| QBREXZA | glycopyrronium tosylate | CLOTH;TOPICAL | 210361 | NDA | Journey Medical Corporation | 69489-411 | 69489-411-30 | 30 POUCH in 1 CARTON (69489-411-30) / 2.8 g in 1 POUCH (69489-411-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CLOTH;TOPICAL | Strength | EQ 2.4% BASE | ||||
| Approval Date: | Jun 28, 2018 | TE: | AB | RLD: | Yes | ||||
| Patent: | 10,004,717 | Patent Expiration: | Feb 28, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER | ||||||||
| Patent: | 10,052,267 | Patent Expiration: | Oct 17, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER | ||||||||
| Patent: | 10,543,192 | Patent Expiration: | Feb 28, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 210361
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Journey | QBREXZA | glycopyrronium tosylate | CLOTH;TOPICAL | 210361-001 | Jun 28, 2018 | 6,433,003 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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