MedPath
FDA Approval

Olanzapine

December 4, 2023

HUMAN PRESCRIPTION DRUG LABEL

Olanzapine(15 mg in 1 1)

Products (4)

Olanzapine

60505-3277

ANDA091265

ANDA (C73584)

ORAL

December 4, 2023

Code: N7U69T4SZRClass: ACTIBQuantity: 15 mg in 1 1
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
CARBOXYMETHYLCELLULOSE CALCIUMInactive
Code: UTY7PDF93LClass: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT

Olanzapine

60505-3278

ANDA091265

ANDA (C73584)

ORAL

December 4, 2023

Code: N7U69T4SZRClass: ACTIBQuantity: 20 mg in 1 1
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
CARBOXYMETHYLCELLULOSE CALCIUMInactive
Code: UTY7PDF93LClass: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT

Olanzapine

60505-3276

ANDA091265

ANDA (C73584)

ORAL

December 4, 2023

Code: N7U69T4SZRClass: ACTIBQuantity: 10 mg in 1 1
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CARBOXYMETHYLCELLULOSE CALCIUMInactive
Code: UTY7PDF93LClass: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT

Olanzapine

60505-3275

ANDA091265

ANDA (C73584)

ORAL

December 4, 2023

Code: N7U69T4SZRClass: ACTIBQuantity: 5 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
CARBOXYMETHYLCELLULOSE CALCIUMInactive
Code: UTY7PDF93LClass: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4Class: IACT
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