Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022203

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ASTEPRO (AZELASTINE HYDROCHLORIDE)
0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: AZELASTINE HYDROCHLORIDE
Proprietary Name: ASTEPRO
Dosage Form; Route of Administration: SPRAY, METERED; NASAL
Strength: 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022203
Product Number: 001
Approval Date: Oct 15, 2008
Applicant Holder Full Name: MYLAN SPECIALTY LP
Marketing Status:  Discontinued
Patent and Exclusivity Information

ASTEPRO (AZELASTINE HYDROCHLORIDE)
0.2055MG/SPRAY
Marketing Status: Discontinued

Active Ingredient: AZELASTINE HYDROCHLORIDE
Proprietary Name: ASTEPRO
Dosage Form; Route of Administration: SPRAY, METERED; NASAL
Strength: 0.2055MG/SPRAY
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N022203
Product Number: 002
Approval Date: Aug 31, 2009
Applicant Holder Full Name: MYLAN SPECIALTY LP
Marketing Status:  Discontinued
Patent and Exclusivity Information