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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 and Sun Pharma Global and is included in two NDAs. It is available from two 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 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.

Suppliers and Packaging for NDA: 078271

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
desmopressin acetate
SPRAY, METERED;NASAL 078271 ANDA Sun Pharma Global FZE 47335-788 47335-788-91 1 BOTTLE, SPRAY in 1 CARTON (47335-788-91) > 5 mL in 1 BOTTLE, SPRAY

Summary 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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