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Generated: November 13, 2018

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Details for New Drug Application (NDA): 020355

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NDA 020355 describes STIMATE (NEEDS NO REFRIGERATION), which is a drug marketed by Ferring Pharms Inc and is included in one NDA. It is available from one supplier. Additional details are available on the STIMATE (NEEDS NO REFRIGERATION) profile page.

The generic ingredient in STIMATE (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 020355
Tradename:STIMATE (NEEDS NO REFRIGERATION)
Applicant:Ferring Pharms Inc
Ingredient:desmopressin acetate
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 020355
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
STIMATE desmopressin acetate SPRAY, METERED;NASAL 020355 NDA CSL Behring LLC 0053-6871 0053-6871-00 1 BOTTLE, SPRAY in 1 CARTON (0053-6871-00) > 2.5 mL in 1 BOTTLE, SPRAY
STIMATE (NEEDS NO REFRIGERATION) desmopressin acetate SPRAY, METERED;NASAL 020355 NDA CSL Behring LLC 0053-6871 0053-6871-00 1 BOTTLE, SPRAY in 1 CARTON (0053-6871-00) > 2.5 mL in 1 BOTTLE, SPRAY

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SPRAY, METERED;NASALStrength0.15MG/SPRAY
Approval Date:Mar 7, 1994TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;NASALStrength0.15MG/SPRAY
Approval Date:Oct 24, 2007TE:RLD:Yes

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