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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 076403

GABAPENTIN (GABAPENTIN)
250MG/5ML
Marketing Status: Prescription
Active Ingredient: GABAPENTIN
Proprietary Name: GABAPENTIN
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 250MG/5ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AA
Application Number: A076403
Product Number: 001
Approval Date: May 1, 2012
Applicant Holder Full Name: ACELLA PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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