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Report / Drug application metadata

OLANZAPINE

The application ANDA201588 lists 1 product formulation. Its sponsor is SANDOZ INC. The product details below come from the application record, not a prescribing guide.

Which products are in this application?

OLANZAPINE

Active ingredients
OLANZAPINE 10MG/VIAL
Dosage form
POWDER
Route
INTRAMUSCULAR
Marketing status
Prescription
Product number
001
Therapeutic equivalence code
AP

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
ANDA201588
Sponsor
SANDOZ INC

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