Details for New Drug Application (NDA): 203660
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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 203660
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: | DISCN | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.05% | ||||
Approval Date: | Nov 8, 2016 | TE: | RLD: | No |
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