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Generated: January 16, 2019

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Details for New Drug Application (NDA): 210861

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NDA 210861 describes VITRAKVI, which is a drug marketed by Loxo Oncology Inc and is included in two NDAs. It is available from one supplier. Additional details are available on the VITRAKVI profile page.

The generic ingredient in VITRAKVI is larotrectinib. One supplier is listed for this compound. Additional details are available on the larotrectinib profile page.
Summary for 210861
Applicant:Loxo Oncology Inc
Suppliers and Packaging for NDA: 210861
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VITRAKVI larotrectinib CAPSULE;ORAL 210861 NDA Loxo Oncology, Inc. 71777-390 71777-390-01 60 CAPSULE in 1 BOTTLE (71777-390-01)
VITRAKVI larotrectinib CAPSULE;ORAL 210861 NDA Loxo Oncology, Inc. 71777-391 71777-391-01 60 CAPSULE in 1 BOTTLE (71777-391-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength25MG
Approval Date:Nov 26, 2018TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Nov 26, 2018TE:RLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

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