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FDA Approval

Olanzapine

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

FDA Approval Summary

Company
Major Pharmaceuticals
DUNS: 191427277
Effective Date
December 11, 2022
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Olanzapine(2.5 mg in 1 1)

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
0904-6283
Application Number
ANDA076255
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
December 11, 2022
Code: N7U69T4SZRClass: ACTIBQuantity: 2.5 mg in 1 1
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MKClass: IACT
Hydroxypropyl Cellulose (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
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