Product Details for ANDA 208615
FONDAPARINUX SODIUM (FONDAPARINUX SODIUM)
2.5MG/0.5ML
Marketing Status: Prescription
5MG/0.4ML
Marketing Status: Prescription
7.5MG/0.6ML
Marketing Status: Prescription
10MG/0.8ML
Marketing Status: Prescription
2.5MG/0.5ML
Marketing Status: Prescription
Active Ingredient: FONDAPARINUX SODIUM
Proprietary Name: FONDAPARINUX SODIUM
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: 2.5MG/0.5ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A208615
Product Number: 001
Approval Date: Nov 14, 2018
Applicant Holder Full Name: SCINOPHARM TAIWAN LTD
Marketing Status: Prescription
Patent and Exclusivity Information
FONDAPARINUX SODIUM (FONDAPARINUX SODIUM)
Proprietary Name: FONDAPARINUX SODIUM
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: 2.5MG/0.5ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A208615
Product Number: 001
Approval Date: Nov 14, 2018
Applicant Holder Full Name: SCINOPHARM TAIWAN LTD
Marketing Status: Prescription
Patent and Exclusivity Information
5MG/0.4ML
Marketing Status: Prescription
Active Ingredient: FONDAPARINUX SODIUM
Proprietary Name: FONDAPARINUX SODIUM
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: 5MG/0.4ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A208615
Product Number: 002
Approval Date: Nov 14, 2018
Applicant Holder Full Name: SCINOPHARM TAIWAN LTD
Marketing Status: Prescription
Patent and Exclusivity Information
FONDAPARINUX SODIUM (FONDAPARINUX SODIUM)
Proprietary Name: FONDAPARINUX SODIUM
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: 5MG/0.4ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A208615
Product Number: 002
Approval Date: Nov 14, 2018
Applicant Holder Full Name: SCINOPHARM TAIWAN LTD
Marketing Status: Prescription
Patent and Exclusivity Information
7.5MG/0.6ML
Marketing Status: Prescription
Active Ingredient: FONDAPARINUX SODIUM
Proprietary Name: FONDAPARINUX SODIUM
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: 7.5MG/0.6ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A208615
Product Number: 003
Approval Date: Nov 14, 2018
Applicant Holder Full Name: SCINOPHARM TAIWAN LTD
Marketing Status: Prescription
Patent and Exclusivity Information
FONDAPARINUX SODIUM (FONDAPARINUX SODIUM)
Proprietary Name: FONDAPARINUX SODIUM
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: 7.5MG/0.6ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A208615
Product Number: 003
Approval Date: Nov 14, 2018
Applicant Holder Full Name: SCINOPHARM TAIWAN LTD
Marketing Status: Prescription
Patent and Exclusivity Information
10MG/0.8ML
Marketing Status: Prescription
Active Ingredient: FONDAPARINUX SODIUM
Proprietary Name: FONDAPARINUX SODIUM
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: 10MG/0.8ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A208615
Product Number: 004
Approval Date: Nov 14, 2018
Applicant Holder Full Name: SCINOPHARM TAIWAN LTD
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: FONDAPARINUX SODIUM
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: 10MG/0.8ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A208615
Product Number: 004
Approval Date: Nov 14, 2018
Applicant Holder Full Name: SCINOPHARM TAIWAN LTD
Marketing Status: Prescription
Patent and Exclusivity Information