Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Bryant Ranch Prepack
171714327
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Bryant Ranch Prepack
Bryant Ranch Prepack
Bryant Ranch Prepack
171714327
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
63629-8719Application Number
ANDA091265Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
October 14, 2021MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
OlanzapineActive
Code: N7U69T4SZRClass: ACTIBQuantity: 20 mg in 1 1
SUCRALOSEInactive
Code: 96K6UQ3ZD4Class: IACT
CARBOXYMETHYLCELLULOSE CALCIUMInactive
Code: UTY7PDF93LClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT