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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
AvPAK
DUNS: 832926666
Effective Date
November 7, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Olanzapine(10 mg in 1 1)

Products3

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
50268-616
Application Number
ANDA091415
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
November 7, 2023
ASPARTAMEInactive
Code: Z0H242BBR1Class: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
Code: N7U69T4SZRClass: ACTIBQuantity: 10 mg in 1 1

OLANZAPINE

Product Details

NDC Product Code
50268-615
Application Number
ANDA091415
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
November 7, 2023
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
ASPARTAMEInactive
Code: Z0H242BBR1Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
Code: N7U69T4SZRClass: ACTIBQuantity: 5 mg in 1 1

OLANZAPINE

Product Details

NDC Product Code
50268-617
Application Number
ANDA091415
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
November 7, 2023
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
ASPARTAMEInactive
Code: Z0H242BBR1Class: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
Code: N7U69T4SZRClass: ACTIBQuantity: 15 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
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