Product Details for NDA 017007
HEPARIN SODIUM (HEPARIN SODIUM)
1,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
2,500 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
5,000 UNITS/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
5,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
7,500 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
10,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
15,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
20,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
1,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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Strength: 1,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N017007
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
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Strength: 1,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N017007
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
2,500 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: 2,500 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N017007
Product Number: 007
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
HEPARIN SODIUM (HEPARIN SODIUM)
Proprietary Name: HEPARIN SODIUM
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 2,500 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N017007
Product Number: 007
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
5,000 UNITS/0.5ML **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/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N017007
Product Number: 010
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
HEPARIN SODIUM (HEPARIN SODIUM)
Proprietary Name: HEPARIN SODIUM
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 5,000 UNITS/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N017007
Product Number: 010
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
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: Yes
Reference Standard: No
TE Code:
Application Number: N017007
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
HEPARIN SODIUM (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: Yes
Reference Standard: No
TE Code:
Application Number: N017007
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
7,500 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: 7,500 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N017007
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
HEPARIN SODIUM (HEPARIN SODIUM)
Proprietary Name: HEPARIN SODIUM
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 7,500 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N017007
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
10,000 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: 10,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N017007
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
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 **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N017007
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
15,000 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: 15,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N017007
Product Number: 005
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
HEPARIN SODIUM (HEPARIN SODIUM)
Proprietary Name: HEPARIN SODIUM
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 15,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N017007
Product Number: 005
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
20,000 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: 20,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N017007
Product Number: 006
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: HEPARIN SODIUM
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 20,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N017007
Product Number: 006
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information