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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 080677

MANNITOL 25% (MANNITOL)
12.5GM/50ML
Marketing Status: Prescription
Active Ingredient: MANNITOL
Proprietary Name: MANNITOL 25%
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 12.5GM/50ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A080677
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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