Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 217314

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LEVOLEUCOVORIN CALCIUM (LEVOLEUCOVORIN CALCIUM)
EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)
Marketing Status: Prescription

Active Ingredient: LEVOLEUCOVORIN CALCIUM
Proprietary Name: LEVOLEUCOVORIN CALCIUM
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A217314
Product Number: 001
Approval Date: May 22, 2023
Applicant Holder Full Name: HAINAN POLY PHARMACEUTICAL CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

LEVOLEUCOVORIN CALCIUM (LEVOLEUCOVORIN CALCIUM)
EQ 250MG BASE/25ML (EQ 10MG BASE/ML)
Marketing Status: Prescription

Active Ingredient: LEVOLEUCOVORIN CALCIUM
Proprietary Name: LEVOLEUCOVORIN CALCIUM
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: EQ 250MG BASE/25ML (EQ 10MG BASE/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A217314
Product Number: 002
Approval Date: May 22, 2023
Applicant Holder Full Name: HAINAN POLY PHARMACEUTICAL CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information