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Last Updated: January 23, 2021

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Details for New Drug Application (NDA): 076703

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NDA 076703 describes DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION), which is a drug marketed by Apotex Inc, Sun Pharm, and Zydus Pharms, and is included in three NDAs. It is available from four suppliers. Additional details are available on the DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION) profile page.

The generic ingredient in DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION) is desmopressin acetate. There are twenty drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the desmopressin acetate profile page.
Summary for 076703
Tradename:DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)
Applicant:Apotex Inc
Ingredient:desmopressin acetate
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 076703
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION) desmopressin acetate SPRAY, METERED;NASAL 076703 ANDA Apotex Corp. 60505-0815 60505-0815-0 1 BOTTLE, SPRAY in 1 CARTON (60505-0815-0) > 50 SPRAY in 1 BOTTLE, SPRAY

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;NASALStrength0.01MG/SPRAY
Approval Date:Jan 27, 2005TE:ABRLD:No

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