NOCDURNA Orally disintegrating tablet Ref.[27533] Active ingredients: Desmopressin

Source: Health Products and Food Branch (CA)  Revision Year: 2014 

Product name

NOCDURNA.

Summary product information

Route of AdministrationDosage Form / Strength Clinically Relevant Non medicinal Ingredients
Sublingual Orally Disintegrating Tablets

Female: 25 µg
Male: 50µg
Gelatin, Mannitol, Citric Acid

Dosage forms, composition and packaging

NOCDURNA is an orally disintegrating tablet containing desmopressin acetate equivalent to 25 or 50 µg of desmopressin as free base. The inactive ingredients are gelatin, mannitol, and anhydrous citric acid.

NOCDURNA 25 µg is a white, round, orally disintegrating tablet with “25” on one side.

NOCDURNA 50 µg is a white, round, orally disintegrating tablet with “50” on one side.

NOCDURNA Initiation Pack for Men >65 Years of Age is packaged as a unit dose blister (4 units per box)

NOCDURNA is packaged as a unit dose blister, 10 units per blister pack, 3 blister packs (30 unit doses) per box.

Marketing Informations Authorization Dates
Authorization holder:

Ferring Inc., 200 Yorkland Boulevard, Suite 500, North York, Ontario, M2J 5C1

Submission control number:

168240

Date of revision:

September 3, 2014

Drugs

Drug Countries
NOCDURNA Canada, Finland, Hong Kong, Israel, Netherlands, Romania, Singapore

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