MedPath
FDA Approval

Olanzapine

October 3, 2022

HUMAN PRESCRIPTION DRUG LABEL

Olanzapine(20 mg in 1 1)

Manufacturing Establishments (1)

Dr.Reddy's Laboratories Limited-FTO3

Dr. Reddy's Laboratories Ltd.

918608162

Products (2)

Olanzapine

55111-168

ANDA076133

ANDA (C73584)

ORAL

November 27, 2019

Code: N7U69T4SZRClass: ACTIBQuantity: 20 mg in 1 1
CrospovidoneInactive
Code: 68401960MKClass: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5XClass: IACT
HYDROXYPROPYL CELLULOSE (110000 WAMW)Inactive
Code: 5Y0974F5PWClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
hypromellosesInactive
Code: 3NXW29V3WOClass: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT

Olanzapine

55111-167

ANDA076133

ANDA (C73584)

ORAL

November 27, 2019

Code: N7U69T4SZRClass: ACTIBQuantity: 15 mg in 1 1
CrospovidoneInactive
Code: 68401960MKClass: IACT
HYDROXYPROPYL CELLULOSE (110000 WAMW)Inactive
Code: 5Y0974F5PWClass: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5XClass: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
hypromellosesInactive
Code: 3NXW29V3WOClass: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
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