ADQUEY Ointment Ref.[116221] Active ingredients: Difamilast

Source: FDA, National Drug Code (US)  Revision Year: 2026 

Product description

ADQUEY (difamilast) ointment contains difamilast as the active ingredient. Difamilast, is a phosphodiesterase-4 (PDE-4) inhibitor.

Difamilast is described chemically as N-({2-[4-(Difluoromethoxy)-3-(propan-2-yloxy)phenyl]-1,3-oxazol-4-yl}methyl)-2-ethoxybenzamide. The empirical formula is C23H24F2N2O5 and the molecular weight is 446.44 g/mol.

The structural formula is represented below:

Difamilast occurs as white (or practically white) crystals or crystalline powder. It is very soluble in N-methylpyrrolidone, freely soluble in methanol and ethanol (99.5), and practically insoluble in water. It shows crystal polymorphism.

Each gram of ADQUEY contains 1% difamilast (w/w) in a wax-based, white to off-white ointment containing the following inactive ingredients: mineral oil, paraffin, propylene carbonate, white petrolatum, and white wax.

Dosage Forms and Strengths

Ointment: 1% (10 mg of difamilast per gram) of white to off-white ointment.

How Supplied

ADQUEY (difamilast) ointment, 1% is a white to off-white ointment supplied in the following packages:

  • 27 g tube (NDC 72893-017-08)
  • 85 g tube (NDC 72893-017-09)

(Made in Canada)

Manufactured for: Acrotech Biopharma Inc, East Windsor, NJ 08520 USA

Drugs

Drug Countries
ADQUEY United States

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