Product Details for NDA 017651
HEPARIN SODIUM (HEPARIN SODIUM)
5,000 UNITS/ML
Marketing Status: Prescription
1,000 UNITS/ML
Marketing Status: Discontinued
10,000 UNITS/ML
Marketing Status: Discontinued
20,000 UNITS/ML
Marketing Status: Discontinued
5,000 UNITS/ML
Marketing Status: Prescription
Active Ingredient: HEPARIN SODIUM
Proprietary Name: HEPARIN SODIUM
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 5,000 UNITS/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N017651
Product Number: 006
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)
Proprietary Name: HEPARIN SODIUM
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 5,000 UNITS/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N017651
Product Number: 006
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status: Prescription
Patent and Exclusivity Information
1,000 UNITS/ML
Marketing Status: Discontinued
Active Ingredient: HEPARIN SODIUM
Proprietary Name: HEPARIN SODIUM
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 1,000 UNITS/ML
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N017651
Product Number: 005
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
HEPARIN SODIUM (HEPARIN SODIUM)
Proprietary Name: HEPARIN SODIUM
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 1,000 UNITS/ML
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N017651
Product Number: 005
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
10,000 UNITS/ML
Marketing Status: Discontinued
Active Ingredient: HEPARIN SODIUM
Proprietary Name: HEPARIN SODIUM
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 10,000 UNITS/ML
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N017651
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
HEPARIN SODIUM (HEPARIN SODIUM)
Proprietary Name: HEPARIN SODIUM
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 10,000 UNITS/ML
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N017651
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
20,000 UNITS/ML
Marketing Status: Discontinued
Active Ingredient: HEPARIN SODIUM
Proprietary Name: HEPARIN SODIUM
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 20,000 UNITS/ML
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N017651
Product Number: 008
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: HEPARIN SODIUM
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 20,000 UNITS/ML
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N017651
Product Number: 008
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status: Discontinued
Patent and Exclusivity Information