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Generated: November 14, 2018

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Details for New Drug Application (NDA): 017922

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NDA 017922 describes DDAVP (NEEDS NO REFRIGERATION), which is a drug marketed by Ferring Pharms Inc and is included in one NDA. It is available from two suppliers. Additional details are available on the DDAVP (NEEDS NO REFRIGERATION) profile page.

The generic ingredient in DDAVP (NEEDS NO REFRIGERATION) 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 017922
Tradename:DDAVP (NEEDS NO REFRIGERATION)
Applicant:Ferring Pharms Inc
Ingredient:desmopressin acetate
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 017922
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DDAVP desmopressin acetate SOLUTION;NASAL 017922 NDA Ferring Pharmaceuticals Inc. 55566-2400 55566-2400-0 1 BOTTLE, PUMP in 1 CARTON (55566-2400-0) > 2.5 mL in 1 BOTTLE, PUMP
DDAVP desmopressin acetate SOLUTION;NASAL 017922 NDA Ferring Pharmaceuticals Inc. 55566-2500 55566-2500-0 1 BOTTLE, PUMP in 1 CARTON (55566-2500-0) > 5 mL in 1 BOTTLE, PUMP

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;NASALStrength0.01%
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:SPRAY, METERED;NASALStrength0.01MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Feb 6, 1989TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;NASALStrength0.01MG/SPRAY
Approval Date:Aug 7, 1996TE:ABRLD:Yes

Expired US Patents for NDA 017922

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ferring Pharms Inc DDAVP desmopressin acetate SPRAY, METERED;NASAL 017922-002 Feb 6, 1989 ➤ Sign Up ➤ Sign Up
Ferring Pharms Inc DDAVP desmopressin acetate SOLUTION;NASAL 017922-001 Approved Prior to Jan 1, 1982 ➤ Sign Up ➤ Sign Up
Ferring Pharms Inc DDAVP desmopressin acetate SOLUTION;NASAL 017922-001 Approved Prior to Jan 1, 1982 ➤ Sign Up ➤ Sign Up
Ferring Pharms Inc DDAVP (NEEDS NO REFRIGERATION) desmopressin acetate SPRAY, METERED;NASAL 017922-003 Aug 7, 1996 ➤ Sign Up ➤ Sign Up
Ferring Pharms Inc DDAVP (NEEDS NO REFRIGERATION) desmopressin acetate SPRAY, METERED;NASAL 017922-003 Aug 7, 1996 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Citi
Queensland Health
Argus Health
US Army
Fish and Richardson
Daiichi Sankyo
Dow
Merck

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