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Generated: January 21, 2019

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Details for New Drug Application (NDA): 078271

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NDA 078271 describes DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION), which is a drug marketed by Apotex Inc, Sun Pharma Global, and Zydus Pharms Usa Inc, and is included in three NDAs. It is available from three 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-five suppliers are listed for this compound. Additional details are available on the desmopressin acetate profile page.
Summary for 078271
Applicant:Sun Pharma Global
Ingredient:desmopressin acetate
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 078271
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION) desmopressin acetate SPRAY, METERED;NASAL 078271 ANDA Sun Pharmaceutical Industries, Inc. 47335-788 47335-788-91 1 BOTTLE, SPRAY in 1 CARTON (47335-788-91) > 5 mL in 1 BOTTLE, SPRAY

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;NASALStrength0.01MG/SPRAY
Approval Date:Dec 23, 2013TE:ABRLD:No

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