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Last Updated: June 21, 2021

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Details for New Drug Application (NDA): 211226

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NDA 211226 describes KHAPZORY, which is a drug marketed by Acrotech and is included in one NDA. It is available from one supplier. Additional details are available on the KHAPZORY profile page.

The generic ingredient in KHAPZORY is levoleucovorin. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the levoleucovorin profile page.
Summary for 211226
Pharmacology for NDA: 211226
Suppliers and Packaging for NDA: 211226
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KHAPZORY levoleucovorin POWDER;INTRAVENOUS 211226 NDA Spectrum Pharmaceuticals, Inc. 68152-112 68152-112-01 1 VIAL in 1 CARTON (68152-112-01) > 3.5 mL in 1 VIAL
KHAPZORY levoleucovorin POWDER;INTRAVENOUS 211226 NDA Spectrum Pharmaceuticals, Inc. 68152-114 68152-114-01 1 VIAL in 1 CARTON (68152-114-01) > 6 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrength175MG/VIAL
Approval Date:Oct 19, 2018TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrength300MG/VIAL
Approval Date:Oct 19, 2018TE:RLD:Yes

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Serving leading biopharmaceutical companies globally:

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