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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 084092

MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCHLORIDE)
25MG
Marketing Status: Prescription
Active Ingredient: MECLIZINE HYDROCHLORIDE
Proprietary Name: MECLIZINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AA
Application Number: A084092
Product Number: 003
Approval Date: May 22, 1989
Applicant Holder Full Name: INVATECH PHARMA SOLUTIONS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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