MedPath
FDA Approval

Olanzapine

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

FDA Approval Summary

Company
Indoco Remedies Limited
DUNS: 650445950
Effective Date
August 14, 2020
Labeling Type
Human Prescription Drug Label
Olanzapine(10 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

INDOCO REMEDIES LIMITED

Indoco Remedies Limited

915851870

Products6

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
14445-109
Application Number
ANDA206155
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
August 14, 2020
OlanzapineActive
Code: N7U69T4SZRClass: ACTIBQuantity: 10 mg in 1 1
CROSPOVIDONEInactive
Code: 68401960MKClass: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671PClass: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT

Olanzapine

Product Details

NDC Product Code
14445-111
Application Number
ANDA206155
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
August 14, 2020
CROSPOVIDONEInactive
Code: 68401960MKClass: IACT
OlanzapineActive
Code: N7U69T4SZRClass: ACTIBQuantity: 20 mg in 1 1
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671PClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT

Olanzapine

Product Details

NDC Product Code
14445-110
Application Number
ANDA206155
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
August 14, 2020
OlanzapineActive
Code: N7U69T4SZRClass: ACTIBQuantity: 15 mg in 1 1
CROSPOVIDONEInactive
Code: 68401960MKClass: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671PClass: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT

Olanzapine

Product Details

NDC Product Code
14445-106
Application Number
ANDA206155
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
August 14, 2020
OlanzapineActive
Code: N7U69T4SZRClass: ACTIBQuantity: 2.5 mg in 1 1
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671PClass: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
CROSPOVIDONEInactive
Code: 68401960MKClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT

Olanzapine

Product Details

NDC Product Code
14445-108
Application Number
ANDA206155
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
August 14, 2020
OlanzapineActive
Code: N7U69T4SZRClass: ACTIBQuantity: 7.5 mg in 1 1
CROSPOVIDONEInactive
Code: 68401960MKClass: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671PClass: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT

Olanzapine

Product Details

NDC Product Code
14445-107
Application Number
ANDA206155
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
August 14, 2020
CROSPOVIDONEInactive
Code: 68401960MKClass: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671PClass: IACT
OlanzapineActive
Code: N7U69T4SZRClass: ACTIBQuantity: 5 mg in 1 1
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
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