Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 212320

Marketing Status: Prescription
Active Ingredient: FERRIC MALTOL
Proprietary Name: ACCRUFER
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 30MG IRON
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N212320
Product Number: 001
Approval Date: Jul 25, 2019
Applicant Holder Full Name: SHIELD TX UK LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

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