Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 204368

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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: A204368
Product Number: 001
Approval Date: Jun 7, 2016
Applicant Holder Full Name: QILU PHARMACEUTICAL HAINAN CO 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: A204368
Product Number: 002
Approval Date: Jun 7, 2016
Applicant Holder Full Name: QILU PHARMACEUTICAL HAINAN CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

OXALIPLATIN (OXALIPLATIN)
200MG/40ML (5MG/ML)
Marketing Status: Prescription

Active Ingredient: OXALIPLATIN
Proprietary Name: OXALIPLATIN
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: 200MG/40ML (5MG/ML)
Reference Listed Drug: No
Reference Standard: Yes
TE Code: 
Application Number: A204368
Product Number: 003
Approval Date: Jun 7, 2016
Applicant Holder Full Name: QILU PHARMACEUTICAL HAINAN CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information