Details for New Drug Application (NDA): 208111
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NDA 208111 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.
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 208111
| Tradename: | AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE |
| Applicant: | Padagis Israel |
| Ingredient: | azelastine hydrochloride; fluticasone propionate |
| Patents: | 0 |
Pharmacology for NDA: 208111
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists Histamine H1 Receptor Antagonists |
Suppliers and Packaging for NDA: 208111
| 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 | 208111 | ANDA | Padagis Israel Pharmaceuticals Ltd | 45802-066 | 45802-066-01 | 1 BOTTLE in 1 CARTON (45802-066-01) / 120 SPRAY, METERED in 1 BOTTLE |
| AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE | azelastine hydrochloride; fluticasone propionate | SPRAY, METERED;NASAL | 208111 | ANDA | Bryant Ranch Prepack | 63629-8612 | 63629-8612-1 | 1 BOTTLE in 1 CARTON (63629-8612-1) / 120 SPRAY, METERED in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SPRAY, METERED;NASAL | Strength | 0.137MG/SPRAY;0.05MG/SPRAY | ||||
| Approval Date: | Feb 18, 2021 | TE: | AB | RLD: | No | ||||
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