Details for New Drug Application (NDA): 212289
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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 212289
Tradename: | AZELASTINE HYDROCHLORIDE |
Applicant: | Aurobindo Pharma Ltd |
Ingredient: | azelastine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 212289
Mechanism of Action | Histamine H1 Receptor Antagonists |
Suppliers and Packaging for NDA: 212289
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AZELASTINE HYDROCHLORIDE | azelastine hydrochloride | SPRAY, METERED;NASAL | 212289 | ANDA | RPK Pharmaceuticals, Inc. | 53002-5279 | 53002-5279-1 | 1 BOTTLE, SPRAY in 1 CARTON (53002-5279-1) / 200 SPRAY, METERED in 1 BOTTLE, SPRAY |
AZELASTINE HYDROCHLORIDE | azelastine hydrochloride | SPRAY, METERED;NASAL | 212289 | ANDA | Aurobindo Pharma Limited | 59651-214 | 59651-214-30 | 1 BOTTLE, SPRAY in 1 CARTON (59651-214-30) / 200 SPRAY, METERED in 1 BOTTLE, SPRAY |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SPRAY, METERED;NASAL | Strength | 0.137MG/SPRAY | ||||
Approval Date: | May 8, 2020 | TE: | AB | RLD: | No |
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