Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Macleods Pharmaceuticals Limited
NorthStar RxLLC
676369519
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
72603-159Application Number
ANDA202862Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 17, 2023OlanzapineActive
Code: N7U69T4SZRClass: ACTIBQuantity: 20 mg in 1 1
CROSPOVIDONEInactive
Code: 68401960MKClass: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OHClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
Olanzapine
Product Details
NDC Product Code
72603-157Application Number
ANDA202862Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 17, 2023OlanzapineActive
Code: N7U69T4SZRClass: ACTIBQuantity: 10 mg in 1 1
CROSPOVIDONEInactive
Code: 68401960MKClass: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OHClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
Olanzapine
Product Details
NDC Product Code
72603-155Application Number
ANDA202862Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 17, 2023OlanzapineActive
Code: N7U69T4SZRClass: ACTIBQuantity: 5 mg in 1 1
CROSPOVIDONEInactive
Code: 68401960MKClass: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OHClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
Olanzapine
Product Details
NDC Product Code
72603-156Application Number
ANDA202862Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 17, 2023OlanzapineActive
Code: N7U69T4SZRClass: ACTIBQuantity: 7.5 mg in 1 1
CROSPOVIDONEInactive
Code: 68401960MKClass: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OHClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
Olanzapine
Product Details
NDC Product Code
72603-154Application Number
ANDA202862Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 17, 2023OlanzapineActive
Code: N7U69T4SZRClass: ACTIBQuantity: 2.5 mg in 1 1
CROSPOVIDONEInactive
Code: 68401960MKClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OHClass: IACT
Olanzapine
Product Details
NDC Product Code
72603-158Application Number
ANDA202862Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 17, 2023CROSPOVIDONEInactive
Code: 68401960MKClass: IACT
OlanzapineActive
Code: N7U69T4SZRClass: ACTIBQuantity: 15 mg in 1 1
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OHClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT