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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021345

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ARIXTRA (FONDAPARINUX SODIUM)
2.5MG/0.5ML
Marketing Status: Prescription
Active Ingredient: FONDAPARINUX SODIUM
Proprietary Name: ARIXTRA
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: 2.5MG/0.5ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N021345
Product Number: 001
Approval Date: Dec 7, 2001
Applicant Holder Full Name: MYLAN IRELAND LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
ARIXTRA (FONDAPARINUX SODIUM)
5MG/0.4ML
Marketing Status: Prescription
Active Ingredient: FONDAPARINUX SODIUM
Proprietary Name: ARIXTRA
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: 5MG/0.4ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N021345
Product Number: 002
Approval Date: May 28, 2004
Applicant Holder Full Name: MYLAN IRELAND LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
ARIXTRA (FONDAPARINUX SODIUM)
7.5MG/0.6ML
Marketing Status: Prescription
Active Ingredient: FONDAPARINUX SODIUM
Proprietary Name: ARIXTRA
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: 7.5MG/0.6ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N021345
Product Number: 003
Approval Date: May 28, 2004
Applicant Holder Full Name: MYLAN IRELAND LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
ARIXTRA (FONDAPARINUX SODIUM)
10MG/0.8ML
Marketing Status: Prescription
Active Ingredient: FONDAPARINUX SODIUM
Proprietary Name: ARIXTRA
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: 10MG/0.8ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N021345
Product Number: 004
Approval Date: May 28, 2004
Applicant Holder Full Name: MYLAN IRELAND LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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