Olanzapine

Manufacturing Establishments (1)

Aurobindo Pharma Limited

Labeler

Aurobindo Pharma Limited

DUNS Number

650381903

Products (4)

NDC Product Code

65862-657

Application Number

ANDA203708

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

May 3, 2020

Ingredients

OlanzapineActive

Code: N7U69T4SZRClass: ACTIBQuantity: 10 mg in 1 1

PINEAPPLEInactive

Code: 2A88ZO081OClass: IACT

ASPARTAMEInactive

Code: Z0H242BBR1Class: IACT

CROSPOVIDONEInactive

Code: 2S7830E561Class: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

SODIUM STEARYL FUMARATEInactive

Code: 7CV7WJK4UIClass: IACT

MANNITOLInactive

Code: 3OWL53L36AClass: IACT

POLACRILIN POTASSIUMInactive

Code: 0BZ5A00FQUClass: IACT

Olanzapine

NDC Product Code

65862-658

Application Number

ANDA203708

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

May 3, 2020

Ingredients

PINEAPPLEInactive

Code: 2A88ZO081OClass: IACT

MANNITOLInactive

Code: 3OWL53L36AClass: IACT

ASPARTAMEInactive

Code: Z0H242BBR1Class: IACT

OlanzapineActive

Code: N7U69T4SZRClass: ACTIBQuantity: 15 mg in 1 1

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

CROSPOVIDONEInactive

Code: 2S7830E561Class: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

POLACRILIN POTASSIUMInactive

Code: 0BZ5A00FQUClass: IACT

SODIUM STEARYL FUMARATEInactive

Code: 7CV7WJK4UIClass: IACT

Olanzapine

NDC Product Code

65862-659

Application Number

ANDA203708

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

May 3, 2020

Ingredients

PINEAPPLEInactive

Code: 2A88ZO081OClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

CROSPOVIDONEInactive

Code: 2S7830E561Class: IACT

OlanzapineActive

Code: N7U69T4SZRClass: ACTIBQuantity: 20 mg in 1 1

ASPARTAMEInactive

Code: Z0H242BBR1Class: IACT

MANNITOLInactive

Code: 3OWL53L36AClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

POLACRILIN POTASSIUMInactive

Code: 0BZ5A00FQUClass: IACT

SODIUM STEARYL FUMARATEInactive

Code: 7CV7WJK4UIClass: IACT

Olanzapine

NDC Product Code

65862-656

Application Number

ANDA203708

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

May 3, 2020

Ingredients

OlanzapineActive

Code: N7U69T4SZRClass: ACTIBQuantity: 5 mg in 1 1

PINEAPPLEInactive

Code: 2A88ZO081OClass: IACT

ASPARTAMEInactive

Code: Z0H242BBR1Class: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

CROSPOVIDONEInactive

Code: 2S7830E561Class: IACT

MANNITOLInactive

Code: 3OWL53L36AClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

POLACRILIN POTASSIUMInactive

Code: 0BZ5A00FQUClass: IACT

SODIUM STEARYL FUMARATEInactive

Code: 7CV7WJK4UIClass: IACT

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Olanzapine

Manufacturing Establishments (1)

Products (4)

Olanzapine

Olanzapine

Olanzapine

Olanzapine