Details for New Drug Application (NDA): 213422
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NDA 213422 describes WYNZORA, which is a drug marketed by MC2 and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the WYNZORA profile page.
The generic ingredient in WYNZORA is betamethasone dipropionate; calcipotriene. There are sixty-six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the betamethasone dipropionate; calcipotriene profile page.
The generic ingredient in WYNZORA is betamethasone dipropionate; calcipotriene. There are sixty-six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the betamethasone dipropionate; calcipotriene profile page.
Summary for 213422
| Tradename: | WYNZORA |
| Applicant: | Mc2 |
| Ingredient: | betamethasone dipropionate; calcipotriene |
| Patents: | 2 |
Pharmacology for NDA: 213422
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 213422
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| WYNZORA | betamethasone dipropionate; calcipotriene | CREAM;TOPICAL | 213422 | NDA | MC2 Therapeutics Ltd | 73499-001 | 73499-001-01 | 1 TUBE in 1 CARTON (73499-001-01) / 60 g in 1 TUBE |
| WYNZORA | betamethasone dipropionate; calcipotriene | CREAM;TOPICAL | 213422 | NDA | MC2 Therapeutics Ltd | 73499-001 | 73499-001-03 | 10 TUBE in 1 CARTON (73499-001-03) / 5 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 0.064%;0.005% | ||||
| Approval Date: | Jul 20, 2020 | TE: | RLD: | Yes | |||||
| Patent: | 10,265,265 | Patent Expiration: | Sep 27, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 11,696,919 | Patent Expiration: | Mar 18, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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