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Generated: January 20, 2019

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Details for New Drug Application (NDA): 201656

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NDA 201656 describes NOCTIVA, which is a drug marketed by Avadel Speclt and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the NOCTIVA profile page.

The generic ingredient in NOCTIVA is desmopressin acetate. There are twenty drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the desmopressin acetate profile page.
Summary for 201656
Tradename:NOCTIVA
Applicant:Avadel Speclt
Ingredient:desmopressin acetate
Patents:4
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 201656
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NOCTIVA desmopressin acetate SPRAY, METERED;NASAL 201656 NDA Avadel Specialty Pharmaceuticals, LLC 71758-106 71758-106-55 1 BOTTLE, SPRAY in 1 CARTON (71758-106-55) > 30 SPRAY, METERED in 1 BOTTLE, SPRAY
NOCTIVA desmopressin acetate SPRAY, METERED;NASAL 201656 NDA Avadel Specialty Pharmaceuticals, LLC 71758-106 71758-106-56 1 BOTTLE, SPRAY in 1 CARTON (71758-106-56) > 30 SPRAY, METERED in 1 BOTTLE, SPRAY

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;NASALStrength0.00083MG/SPRAY
Approval Date:Mar 3, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Mar 3, 2020
Regulatory Exclusivity Use:NEW PRODUCT
Patent:➤ Sign UpPatent Expiration:May 6, 2023Product Flag?Substance Flag?Delist Request?
Patented Use:A METHOD OF TREATING NOCTURIA DUE TO NOCTURNAL POLYURIA IN ADULTS
Patent:➤ Sign UpPatent Expiration:May 6, 2023Product Flag?Substance Flag?Delist Request?
Patented Use:A METHOD OF TREATING NOCTURIA DUE TO NOCTURNAL POLYURIA IN ADULTS

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