Product Details for NDA 017037
HEPARIN SODIUM (HEPARIN SODIUM)
1,000 UNITS/ML
Marketing Status: Prescription
5,000 UNITS/ML
Marketing Status: Prescription
5,000 UNITS/0.5ML
Marketing Status: Prescription
10,000 UNITS/ML
Marketing Status: Prescription
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: N017037
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status: Prescription
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: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N017037
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
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: N017037
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
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: N017037
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
5,000 UNITS/0.5ML
Marketing Status: Prescription
Active Ingredient: HEPARIN SODIUM
Proprietary Name: HEPARIN SODIUM
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 5,000 UNITS/0.5ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: N017037
Product Number: 013
Approval Date: Apr 7, 1986
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
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/0.5ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: N017037
Product Number: 013
Approval Date: Apr 7, 1986
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
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: N017037
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
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: N017037
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information