Product Details for NDA 018609
HEPARIN SODIUM 1,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (HEPARIN SODIUM)
200 UNITS/100ML
Marketing Status: Prescription
200 UNITS/100ML
Marketing Status: Prescription
2,000 UNITS/1000ML
Marketing Status: Prescription
500 UNITS/100ML
Marketing Status: Discontinued
200 UNITS/100ML
Marketing Status: Prescription
Active Ingredient: HEPARIN SODIUM
Proprietary Name: HEPARIN SODIUM 1,000 UNITS AND 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: N018609
Product Number: 001
Approval Date: Apr 28, 1982
Applicant Holder Full Name: BAXTER HEALTHCARE CORP
Marketing Status: Prescription
Patent and Exclusivity Information
HEPARIN SODIUM 2,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (HEPARIN SODIUM)
Proprietary Name: HEPARIN SODIUM 1,000 UNITS AND 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: N018609
Product Number: 001
Approval Date: Apr 28, 1982
Applicant Holder Full Name: BAXTER HEALTHCARE CORP
Marketing Status: Prescription
Patent and Exclusivity Information
200 UNITS/100ML
Marketing Status: Prescription
Active Ingredient: HEPARIN SODIUM
Proprietary Name: HEPARIN SODIUM 2,000 UNITS AND 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: N018609
Product Number: 002
Approval Date: Apr 28, 1982
Applicant Holder Full Name: BAXTER HEALTHCARE CORP
Marketing Status: Prescription
Patent and Exclusivity Information
HEPARIN SODIUM 2,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (HEPARIN SODIUM)
Proprietary Name: HEPARIN SODIUM 2,000 UNITS AND 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: N018609
Product Number: 002
Approval Date: Apr 28, 1982
Applicant Holder Full Name: BAXTER HEALTHCARE CORP
Marketing Status: Prescription
Patent and Exclusivity Information
2,000 UNITS/1000ML
Marketing Status: Prescription
Active Ingredient: HEPARIN SODIUM
Proprietary Name: HEPARIN SODIUM 2,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 2,000 UNITS/1000ML
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N018609
Product Number: 004
Approval Date: Apr 23, 2020
Applicant Holder Full Name: BAXTER HEALTHCARE CORP
Marketing Status: Prescription
Patent and Exclusivity Information
HEPARIN SODIUM 5,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (HEPARIN SODIUM)
Proprietary Name: HEPARIN SODIUM 2,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 2,000 UNITS/1000ML
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N018609
Product Number: 004
Approval Date: Apr 23, 2020
Applicant Holder Full Name: BAXTER HEALTHCARE CORP
Marketing Status: Prescription
Patent and Exclusivity Information
500 UNITS/100ML
Marketing Status: Discontinued
Active Ingredient: HEPARIN SODIUM
Proprietary Name: HEPARIN SODIUM 5,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 500 UNITS/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N018609
Product Number: 003
Approval Date: Apr 28, 1982
Applicant Holder Full Name: BAXTER HEALTHCARE CORP
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: HEPARIN SODIUM 5,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 500 UNITS/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N018609
Product Number: 003
Approval Date: Apr 28, 1982
Applicant Holder Full Name: BAXTER HEALTHCARE CORP
Marketing Status: Discontinued
Patent and Exclusivity Information