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Report / Drug application metadata

JAYPIRCA

The application NDA216059 lists 2 product formulations. Its sponsor is LOXO ONCOL. The product details below come from the application record, not a prescribing guide.

Which products are in this application?

JAYPIRCA

Active ingredients
PIRTOBRUTINIB 50MG
Dosage form
TABLET
Route
ORAL
Marketing status
Prescription
Product number
001

JAYPIRCA

Active ingredients
PIRTOBRUTINIB 100MG
Dosage form
TABLET
Route
ORAL
Marketing status
Prescription
Product number
002

How should this information be used?

An application can contain several product versions and a history of submissions. The details shown here do not establish current availability in a particular country or pharmacy, and a listed strength is not a recommended dose. Check the current approved product label for indications, contraindications, warnings and dosing.

This page does not infer a medicine's treatment uses from its name or regulatory status. Application metadata is evidence about the listed product, not evidence that it is suitable for an individual patient.

Kind
Drug application metadata
Identifier
NDA216059
Sponsor
LOXO ONCOL

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