Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 210124

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FLUOROURACIL (FLUOROURACIL)
2.5GM/50ML (50MG/ML)
Marketing Status: Prescription

Active Ingredient: FLUOROURACIL
Proprietary Name: FLUOROURACIL
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 2.5GM/50ML (50MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A210124
Product Number: 001
Approval Date: Dec 26, 2017
Applicant Holder Full Name: GLAND PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

FLUOROURACIL (FLUOROURACIL)
5GM/100ML (50MG/ML)
Marketing Status: Prescription

Active Ingredient: FLUOROURACIL
Proprietary Name: FLUOROURACIL
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 5GM/100ML (50MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A210124
Product Number: 002
Approval Date: Dec 26, 2017
Applicant Holder Full Name: GLAND PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information