Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 019953

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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: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N019953
Product Number: 001
Approval Date: Jul 20, 1992
Applicant Holder Full Name: B BRAUN MEDICAL INC
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: Yes
Reference Standard: Yes
TE Code: 
Application Number: N019953
Product Number: 002
Approval Date: Dec 15, 2023
Applicant Holder Full Name: B BRAUN MEDICAL INC
Marketing Status:  Prescription
Patent and Exclusivity Information