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Details for New Drug Application (NDA): 022203
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The generic ingredient in ASTEPRO is azelastine hydrochloride. There are twelve drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the azelastine hydrochloride profile page.
Summary for 022203
Tradename: | ASTEPRO |
Applicant: | Mylan Speciality Lp |
Ingredient: | azelastine hydrochloride |
Patents: | 3 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 022203
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ASTEPRO | azelastine hydrochloride | SPRAY, METERED;NASAL | 022203 | NDA AUTHORIZED GENERIC | Wallace Pharmaceuticals Inc. | 51525-0234 | 51525-0234-3 | 1 BOTTLE in 1 CARTON (51525-0234-3) > 200 SPRAY, METERED in 1 BOTTLE |
Paragraph IV (Patent) Challenges for 022203
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
ASTEPRO | SPRAY, METERED;NASAL | azelastine hydrochloride | 022203 | 2011-12-15 |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | SPRAY, METERED;NASAL | Strength | EQ 0.125MG BASE/SPRAY | ||||
Approval Date: | Oct 15, 2008 | TE: | RLD: | No | |||||
Patent: | Start Trial | Patent Expiration: | Jun 4, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | Start Trial | Patent Expiration: | Nov 22, 2025 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF ALLERGIC RHINITIS, INCLUDING SEASONAL AND PERENNIAL ALLERGIC RHINITIS |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | SPRAY, METERED;NASAL | Strength | EQ 0.1876MG BASE/SPRAY | ||||
Approval Date: | Aug 31, 2009 | TE: | AB | RLD: | Yes | ||||
Patent: | Start Trial | Patent Expiration: | Jun 4, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? |
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