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 |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | SPRAY, METERED;NASAL | Strength | 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Oct 15, 2008 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jun 4, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | 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: | DISCN | Dosage: | SPRAY, METERED;NASAL | Strength | 0.2055MG/SPRAY | ||||
Approval Date: | Aug 31, 2009 | TE: | RLD: | No | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jun 4, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? |
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