Details for New Drug Application (NDA): 207712
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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.
Summary for 207712
Tradename: | AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE |
Applicant: | Apotex |
Ingredient: | azelastine hydrochloride; fluticasone propionate |
Patents: | 0 |
Pharmacology for NDA: 207712
Mechanism of Action | Corticosteroid Hormone Receptor Agonists Histamine H1 Receptor Antagonists |
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: | RX | Dosage: | SPRAY, METERED;NASAL | Strength | 0.137MG/SPRAY;0.05MG/SPRAY | ||||
Approval Date: | Apr 28, 2017 | TE: | AB | RLD: | No |
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