Report / Drug application metadata
ROZLYTREK
The application NDA212725 lists 2 product formulations. Its sponsor is GENENTECH INC. The product details below come from the application record, not a prescribing guide.
Which products are in this application?
ROZLYTREK
- Active ingredients
- ENTRECTINIB 200MG
- Dosage form
- CAPSULE
- Route
- ORAL
- Marketing status
- Prescription
- Product number
- 002
ROZLYTREK
- Active ingredients
- ENTRECTINIB 100MG
- Dosage form
- CAPSULE
- Route
- ORAL
- Marketing status
- Prescription
- Product number
- 001
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
- NDA212725
- Sponsor
- GENENTECH INC