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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 075819

AMANTADINE HYDROCHLORIDE (AMANTADINE HYDROCHLORIDE)
50MG/5ML
Marketing Status: Prescription
Active Ingredient: AMANTADINE HYDROCHLORIDE
Proprietary Name: AMANTADINE HYDROCHLORIDE
Dosage Form; Route of Administration: SYRUP; ORAL
Strength: 50MG/5ML
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AA
Application Number: A075819
Product Number: 001
Approval Date: Sep 11, 2002
Applicant Holder Full Name: CMP PHARMA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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