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Generated: November 18, 2018

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Details for New Drug Application (NDA): 022517

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NDA 022517 describes NOCDURNA, which is a drug marketed by Ferring Pharms Inc and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug. Additional details are available on the NOCDURNA profile page.

The generic ingredient in NOCDURNA is desmopressin acetate. There are twenty drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the desmopressin acetate profile page.
Summary for 022517
Tradename:NOCDURNA
Applicant:Ferring Pharms Inc
Ingredient:desmopressin acetate
Patents:7
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 022517
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NOCDURNA desmopressin acetate TABLET;SUBLINGUAL 022517 NDA Ferring Pharmaceuticals Inc. 55566-5050 55566-5050-1 3 BLISTER PACK in 1 CARTON (55566-5050-1) > 10 TABLET in 1 BLISTER PACK (55566-5050-0)
NOCDURNA desmopressin acetate TABLET;SUBLINGUAL 022517 NDA Ferring Pharmaceuticals Inc. 55566-5070 55566-5070-1 3 BLISTER PACK in 1 CARTON (55566-5070-1) > 10 TABLET in 1 BLISTER PACK (55566-5070-0)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;SUBLINGUALStrength0.0277MG
Approval Date:Jun 21, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:Jun 21, 2021
Regulatory Exclusivity Use:NEW PRODUCT
Patent:➤ Sign UpPatent Expiration:Feb 2, 2024Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF NOCTURIA DUE TO NOCTURNAL POLYURIA IN ADULTS
Patent:➤ Sign UpPatent Expiration:Dec 29, 2023Product Flag?YSubstance Flag?Delist Request?

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