Olanzapine

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

Company

DUNS: 005387188

Effective Date

April 27, 2020

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Olanzapine(10 mg in 2 mL)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

0781-3159

Application Number

ANDA201588

Marketing Category

ANDA (C73584)

Route of Administration

INTRAMUSCULAR

Effective Date

July 30, 2015

Ingredients

Code: N7U69T4SZRClass: ACTIBQuantity: 10 mg in 2 mL

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACTQuantity: 50 mg in 2 mL

TARTARIC ACIDInactive

Code: W4888I119HClass: IACTQuantity: 3.5 mg in 2 mL

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT