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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 205529

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OXALIPLATIN (OXALIPLATIN)
50MG/10ML (5MG/ML)
Marketing Status: Prescription
Active Ingredient: OXALIPLATIN
Proprietary Name: OXALIPLATIN
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: 50MG/10ML (5MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A205529
Product Number: 001
Approval Date: Sep 6, 2017
Applicant Holder Full Name: EUGIA PHARMA SPECIALITIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
OXALIPLATIN (OXALIPLATIN)
100MG/20ML (5MG/ML)
Marketing Status: Prescription
Active Ingredient: OXALIPLATIN
Proprietary Name: OXALIPLATIN
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: 100MG/20ML (5MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A205529
Product Number: 002
Approval Date: Sep 6, 2017
Applicant Holder Full Name: EUGIA PHARMA SPECIALITIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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