Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Aspiro Pharma Limited
Camber Pharmaceuticals, Inc.
872341023
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Olanzapine
Product Details
NDC Product Code
31722-308Application Number
ANDA217466Marketing Category
ANDA (C73584)Route of Administration
INTRAMUSCULAREffective Date
April 3, 2023LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACTQuantity: 50 mg in 2 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
OlanzapineActive
Code: N7U69T4SZRClass: ACTIBQuantity: 10 mg in 2 mL
TARTARIC ACIDInactive
Code: W4888I119HClass: IACTQuantity: 3.5 mg in 2 mL