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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 209620

AZELASTINE HYDROCHLORIDE (AZELASTINE HYDROCHLORIDE)
0.05%
Marketing Status: Prescription
Active Ingredient: AZELASTINE HYDROCHLORIDE
Proprietary Name: AZELASTINE HYDROCHLORIDE
Dosage Form; Route of Administration: SOLUTION/DROPS; OPHTHALMIC
Strength: 0.05%
Reference Listed Drug: No
Reference Standard: No
TE Code: AT
Application Number: A209620
Product Number: 001
Approval Date: Mar 20, 2019
Applicant Holder Full Name: ALEMBIC PHARMACEUTICALS LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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