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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 203853

ACETYLCYSTEINE (ACETYLCYSTEINE)
20%
Marketing Status: Prescription
Active Ingredient: ACETYLCYSTEINE
Proprietary Name: ACETYLCYSTEINE
Dosage Form; Route of Administration: SOLUTION; INHALATION, ORAL
Strength: 20%
Reference Listed Drug: No
Reference Standard: No
TE Code: AN
Application Number: A203853
Product Number: 001
Approval Date: Jun 21, 2012
Applicant Holder Full Name: ALVOGEN INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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