Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 212441

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HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (HEPARIN SODIUM)
200 UNITS/100ML
Marketing Status: Prescription

Active Ingredient: HEPARIN SODIUM
Proprietary Name: HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 200 UNITS/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A212441
Product Number: 001
Approval Date: Jul 24, 2020
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (HEPARIN SODIUM)
200 UNITS/100ML
Marketing Status: Prescription

Active Ingredient: HEPARIN SODIUM
Proprietary Name: HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 200 UNITS/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A212441
Product Number: 002
Approval Date: Jul 24, 2020
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information