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Generated: April 29, 2017

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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 Csl Behring 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 nineteen 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 NDA: 020355

Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Pituitary)
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 020355

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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
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

Summary for product number 001

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

Summary 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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