You are 3 steps away
from making better decisions

Serving leading biopharmaceutical companies globally:

Johnson and Johnson

Last Updated: January 15, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091345

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

NDA 091345 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 091345
Applicant:Zydus Pharms
Ingredient:desmopressin acetate
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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:


Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.