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Product Details for NDA 212035

ARGATROBAN IN SODIUM CHLORIDE (ARGATROBAN)
50MG/50ML (1MG/ML)
Marketing Status: Prescription
Active Ingredient: ARGATROBAN
Proprietary Name: ARGATROBAN IN SODIUM CHLORIDE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 50MG/50ML (1MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N212035
Product Number: 001
Approval Date: Jun 7, 2021
Applicant Holder Full Name: ACCORD HEALTHCARE INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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