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. Thirteen suppliers are listed for this compound. Additional details are available on the brimonidine tartrate profile page.
The generic ingredient in MIRVASO is brimonidine tartrate. There are eleven drug master file entries for this compound. Thirteen 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
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: | See Plans and Pricing | Patent Expiration: | Jun 13, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | See Plans and Pricing | Patent Expiration: | Aug 25, 2025 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TOPICAL TREATMENT OF FACIAL ERYTHEMA OF ROSACEA | ||||||||
| Patent: | See Plans and Pricing | Patent Expiration: | Jun 13, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TOPICAL TREATMENT OF FACIAL ERYTHEMA OF ROSACEA | ||||||||
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