Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 017029

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HEPARIN SODIUM (HEPARIN SODIUM)
1,000 UNITS/ML
Marketing Status: Prescription

Active Ingredient: HEPARIN SODIUM
Proprietary Name: HEPARIN SODIUM
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 1,000 UNITS/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N017029
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

HEPARIN SODIUM (HEPARIN SODIUM)
10,000 UNITS/ML
Marketing Status: Prescription

Active Ingredient: HEPARIN SODIUM
Proprietary Name: HEPARIN SODIUM
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 10,000 UNITS/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N017029
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

HEPARIN SODIUM (HEPARIN SODIUM)
10,000 UNITS/ML
Marketing Status: Prescription

Active Ingredient: HEPARIN SODIUM
Proprietary Name: HEPARIN SODIUM
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 10,000 UNITS/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N017029
Product Number: 020
Approval Date: Mar 31, 2011
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

HEPARIN SODIUM (HEPARIN SODIUM)
20,000 UNITS/ML
Marketing Status: Prescription

Active Ingredient: HEPARIN SODIUM
Proprietary Name: HEPARIN SODIUM
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 20,000 UNITS/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N017029
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% (HEPARIN SODIUM)
40 UNITS/ML
Marketing Status: Prescription

Active Ingredient: HEPARIN SODIUM
Proprietary Name: HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5%
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 40 UNITS/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N017029
Product Number: 021
Approval Date: Aug 24, 2017
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% (HEPARIN SODIUM)
50 UNITS/ML
Marketing Status: Prescription

Active Ingredient: HEPARIN SODIUM
Proprietary Name: HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5%
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 50 UNITS/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N017029
Product Number: 022
Approval Date: Aug 24, 2017
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% (HEPARIN SODIUM)
100 UNITS/ML
Marketing Status: Prescription

Active Ingredient: HEPARIN SODIUM
Proprietary Name: HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5%
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 100 UNITS/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N017029
Product Number: 023
Approval Date: Aug 24, 2017
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% (HEPARIN SODIUM)
50 UNITS/ML
Marketing Status: Prescription

Active Ingredient: HEPARIN SODIUM
Proprietary Name: HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45%
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 50 UNITS/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N017029
Product Number: 024
Approval Date: Aug 24, 2017
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% (HEPARIN SODIUM)
100 UNITS/ML
Marketing Status: Prescription

Active Ingredient: HEPARIN SODIUM
Proprietary Name: HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45%
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 100 UNITS/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N017029
Product Number: 025
Approval Date: Aug 24, 2017
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

HEPARIN SODIUM IN PLASTIC CONTAINER (HEPARIN SODIUM)
1,000 UNITS/ML
Marketing Status: Prescription

Active Ingredient: HEPARIN SODIUM
Proprietary Name: HEPARIN SODIUM IN PLASTIC CONTAINER
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 1,000 UNITS/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N017029
Product Number: 013
Approval Date: Dec 5, 1985
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

HEPARIN SODIUM IN PLASTIC CONTAINER (HEPARIN SODIUM)
5,000 UNITS/ML
Marketing Status: Prescription

Active Ingredient: HEPARIN SODIUM
Proprietary Name: HEPARIN SODIUM IN PLASTIC CONTAINER
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 5,000 UNITS/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N017029
Product Number: 014
Approval Date: Dec 5, 1985
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

HEPARIN SODIUM IN PLASTIC CONTAINER (HEPARIN SODIUM)
10,000 UNITS/ML
Marketing Status: Prescription

Active Ingredient: HEPARIN SODIUM
Proprietary Name: HEPARIN SODIUM IN PLASTIC CONTAINER
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 10,000 UNITS/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N017029
Product Number: 015
Approval Date: Dec 5, 1985
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

HEPARIN SODIUM IN PLASTIC CONTAINER (HEPARIN SODIUM)
20,000 UNITS/ML
Marketing Status: Prescription

Active Ingredient: HEPARIN SODIUM
Proprietary Name: HEPARIN SODIUM IN PLASTIC CONTAINER
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 20,000 UNITS/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N017029
Product Number: 016
Approval Date: Dec 5, 1985
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

HEPARIN SODIUM PRESERVATIVE FREE (HEPARIN SODIUM)
1,000 UNITS/ML
Marketing Status: Prescription

Active Ingredient: HEPARIN SODIUM
Proprietary Name: HEPARIN SODIUM PRESERVATIVE FREE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 1,000 UNITS/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N017029
Product Number: 010
Approval Date: Apr 28, 1986
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

HEPARIN SODIUM PRESERVATIVE FREE (HEPARIN SODIUM)
10,000 UNITS/ML
Marketing Status: Prescription

Active Ingredient: HEPARIN SODIUM
Proprietary Name: HEPARIN SODIUM PRESERVATIVE FREE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 10,000 UNITS/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N017029
Product Number: 019
Approval Date: Nov 22, 2010
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

HEPARIN SODIUM (HEPARIN SODIUM)
5,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: HEPARIN SODIUM
Proprietary Name: HEPARIN SODIUM
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 5,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N017029
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information