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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 091316

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FONDAPARINUX SODIUM (FONDAPARINUX SODIUM)
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: A091316
Product Number: 001
Approval Date: Jul 11, 2011
Applicant Holder Full Name: DR REDDYS LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
FONDAPARINUX SODIUM (FONDAPARINUX SODIUM)
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: A091316
Product Number: 002
Approval Date: Jul 11, 2011
Applicant Holder Full Name: DR REDDYS LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
FONDAPARINUX SODIUM (FONDAPARINUX SODIUM)
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: A091316
Product Number: 003
Approval Date: Jul 11, 2011
Applicant Holder Full Name: DR REDDYS LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
FONDAPARINUX SODIUM (FONDAPARINUX SODIUM)
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: A091316
Product Number: 004
Approval Date: Jul 11, 2011
Applicant Holder Full Name: DR REDDYS LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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