Details for New Drug Application (NDA): 213422

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. Eight 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:		Patent Expiration:	Sep 27, 2027	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:		Patent Expiration:	Mar 18, 2039	Product Flag?	Y	Substance Flag?		Delist Request?

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