Details for New Drug Application (NDA): 202743
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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 202743
Tradename: | AZELASTINE HYDROCHLORIDE |
Applicant: | Padagis Israel |
Ingredient: | azelastine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 202743
Mechanism of Action | Histamine H1 Receptor Antagonists |
Suppliers and Packaging for NDA: 202743
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AZELASTINE HYDROCHLORIDE | azelastine hydrochloride | SPRAY, METERED;NASAL | 202743 | ANDA | Padagis Israel Pharmaceuticals Ltd | 45802-026 | 45802-026-83 | 1 BOTTLE in 1 CARTON (45802-026-83) / 200 SPRAY in 1 BOTTLE |
AZELASTINE HYDROCHLORIDE | azelastine hydrochloride | SPRAY, METERED;NASAL | 202743 | ANDA | Bryant Ranch Prepack | 63629-2519 | 63629-2519-1 | 1 BOTTLE in 1 CARTON (63629-2519-1) / 200 SPRAY in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | SPRAY, METERED;NASAL | Strength | 0.2055MG/SPRAY | ||||
Approval Date: | May 8, 2014 | TE: | RLD: | No |
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