Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 203851

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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: No
Reference Standard: No
TE Code: AP
Application Number: A203851
Product Number: 001
Approval Date: Nov 30, 2017
Applicant Holder Full Name: MYLAN LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

HEPARIN SODIUM (HEPARIN SODIUM)
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: No
Reference Standard: No
TE Code: AP
Application Number: A203851
Product Number: 002
Approval Date: Nov 30, 2017
Applicant Holder Full Name: MYLAN LABORATORIES LTD
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: No
Reference Standard: No
TE Code: AP
Application Number: A203851
Product Number: 003
Approval Date: Nov 30, 2017
Applicant Holder Full Name: MYLAN LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information