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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 040607

ACETIC ACID (ACETIC ACID, GLACIAL)
2%
Marketing Status: Prescription
Active Ingredient: ACETIC ACID, GLACIAL
Proprietary Name: ACETIC ACID
Dosage Form; Route of Administration: SOLUTION/DROPS; OTIC
Strength: 2%
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AT
Application Number: A040607
Product Number: 001
Approval Date: Feb 24, 2005
Applicant Holder Full Name: SAPTALIS PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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