Details for New Drug Application (NDA): 090176
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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 090176
Tradename: | AZELASTINE HYDROCHLORIDE |
Applicant: | Bionpharma |
Ingredient: | azelastine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 090176
Mechanism of Action | Histamine H1 Receptor Antagonists |
Suppliers and Packaging for NDA: 090176
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AZELASTINE HYDROCHLORIDE | azelastine hydrochloride | SPRAY, METERED;NASAL | 090176 | ANDA | A-S Medication Solutions | 50090-5271 | 50090-5271-0 | 1 BOTTLE, SPRAY in 1 CARTON (50090-5271-0) / 30 mL in 1 BOTTLE, SPRAY |
AZELASTINE HYDROCHLORIDE | azelastine hydrochloride | SPRAY, METERED;NASAL | 090176 | ANDA | Breckenridge Pharmaceutical, Inc. | 51991-814 | 51991-814-03 | 1 BOTTLE, SPRAY in 1 CARTON (51991-814-03) / 30 mL in 1 BOTTLE, SPRAY |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SPRAY, METERED;NASAL | Strength | 0.137MG/SPRAY | ||||
Approval Date: | Jul 28, 2015 | TE: | AB | RLD: | No |
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