You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 2, 2024

Details for New Drug Application (NDA): 207712


✉ Email this page to a colleague

« Back to Dashboard


NDA 207712 describes AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE, which is a drug marketed by Apotex and Padagis Israel and is included in two NDAs. It is available from three suppliers. Additional details are available on the AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE profile page.

The generic ingredient in AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE is azelastine hydrochloride; fluticasone propionate. There are twelve drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the azelastine hydrochloride; fluticasone propionate profile page.
Pharmacology for NDA: 207712
Suppliers and Packaging for NDA: 207712
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE azelastine hydrochloride; fluticasone propionate SPRAY, METERED;NASAL 207712 ANDA Apotex Corp. 60505-0953 60505-0953-3 1 BOTTLE, SPRAY in 1 CARTON (60505-0953-3) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY
AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE azelastine hydrochloride; fluticasone propionate SPRAY, METERED;NASAL 207712 ANDA Bryant Ranch Prepack 72162-2127 72162-2127-2 1 BOTTLE, SPRAY in 1 CARTON (72162-2127-2) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;NASALStrength0.137MG/SPRAY;0.05MG/SPRAY
Approval Date:Apr 28, 2017TE:ABRLD:No

Complete Access Available with Subscription

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

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.