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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
Qilu Pharmaceutical Co., Ltd.
DUNS: 653878256
Effective Date
May 1, 2018
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Olanzapine(5 mg in 1 1)

Manufacturing Establishments2

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

Qilu Pharmaceutical Co., Ltd.(High Tech Zone Site)

Qilu Pharmaceutical Co., Ltd.

421279342

Qilu Pharmaceutical Co., Ltd.

Qilu Pharmaceutical Co., Ltd.

653878256

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
67184-0562
Application Number
ANDA204319
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
May 1, 2018
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OHClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
OlanzapineActive
Code: N7U69T4SZRClass: ACTIBQuantity: 5 mg in 1 1
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT

Olanzapine

Product Details

NDC Product Code
67184-0566
Application Number
ANDA204319
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
May 1, 2018
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OHClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
OlanzapineActive
Code: N7U69T4SZRClass: ACTIBQuantity: 20 mg in 1 1

Olanzapine

Product Details

NDC Product Code
67184-0561
Application Number
ANDA204319
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
May 1, 2018
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OHClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
OlanzapineActive
Code: N7U69T4SZRClass: ACTIBQuantity: 2.5 mg in 1 1

Olanzapine

Product Details

NDC Product Code
67184-0563
Application Number
ANDA204319
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
May 1, 2018
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OHClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
OlanzapineActive
Code: N7U69T4SZRClass: ACTIBQuantity: 7.5 mg in 1 1

Olanzapine

Product Details

NDC Product Code
67184-0564
Application Number
ANDA204319
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
May 1, 2018
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OHClass: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
OlanzapineActive
Code: N7U69T4SZRClass: ACTIBQuantity: 10 mg in 1 1
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT

Olanzapine

Product Details

NDC Product Code
67184-0565
Application Number
ANDA204319
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
May 1, 2018
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OHClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
OlanzapineActive
Code: N7U69T4SZRClass: ACTIBQuantity: 15 mg in 1 1
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
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