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Generated: December 18, 2018

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Details for New Drug Application (NDA): 091345

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NDA 091345 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-four suppliers are listed for this compound. Additional details are available on the desmopressin acetate profile page.
Summary for 091345
Tradename:DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)
Applicant:Zydus Pharms Usa Inc
Ingredient:desmopressin acetate
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 091345
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION) desmopressin acetate SPRAY, METERED;NASAL 091345 ANDA Zydus Pharmaceuticals (USA) Inc. 68382-384 68382-384-01 5 mL in 1 BOTTLE, SPRAY (68382-384-01)
DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION) desmopressin acetate SPRAY, METERED;NASAL 091345 ANDA Cadila Healthcare Limited 70771-1314 70771-1314-1 5 mL in 1 BOTTLE, SPRAY (70771-1314-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;NASALStrength0.01MG/SPRAY
Approval Date:Oct 3, 2017TE:ABRLD:No

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