Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022562

CARBAGLU (CARGLUMIC ACID)
200MG
Marketing Status: Prescription
Active Ingredient: CARGLUMIC ACID
Proprietary Name: CARBAGLU
Dosage Form; Route of Administration: TABLET, FOR SUSPENSION; ORAL
Strength: 200MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N022562
Product Number: 001
Approval Date: Mar 18, 2010
Applicant Holder Full Name: RECORDATI RARE DISEASES INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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