Details for New Drug Application (NDA): 207610
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The generic ingredient in AZELASTINE HYDROCHLORIDE 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.
Summary for 207610
Tradename: | AZELASTINE HYDROCHLORIDE |
Applicant: | Epic Pharma Llc |
Ingredient: | azelastine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SPRAY, METERED;NASAL | Strength | 0.137MG/SPRAY | ||||
Approval Date: | May 17, 2019 | TE: | AB | RLD: | No |
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