Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 211226

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KHAPZORY (LEVOLEUCOVORIN)
175MG/VIAL
Marketing Status: Prescription

Active Ingredient: LEVOLEUCOVORIN
Proprietary Name: KHAPZORY
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: 175MG/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N211226
Product Number: 001
Approval Date: Oct 19, 2018
Applicant Holder Full Name: ACROTECH BIOPHARMA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

KHAPZORY (LEVOLEUCOVORIN)
300MG/VIAL
Marketing Status: Discontinued

Active Ingredient: LEVOLEUCOVORIN
Proprietary Name: KHAPZORY
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: 300MG/VIAL
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N211226
Product Number: 002
Approval Date: Oct 19, 2018
Applicant Holder Full Name: ACROTECH BIOPHARMA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information