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FDA Drug information

Olanzapine

Read time: 1 mins
Marketing start date: 18 Jun 2024

Summary of product characteristics


Effective Time

20230927

Version

6

Spl Product Data Elements

olanzapine olanzapine OLANZAPINE OLANZAPINE CROSPOVIDONE HYPROMELLOSES LACTOSE MONOHYDRATE LECITHIN, SOYBEAN MAGNESIUM STEARATE TALC TITANIUM DIOXIDE XANTHAN GUM WHITE TO OFF-WHITE ROUND ZF28 olanzapine olanzapine OLANZAPINE OLANZAPINE CROSPOVIDONE HYPROMELLOSES LACTOSE MONOHYDRATE LECITHIN, SOYBEAN MAGNESIUM STEARATE TALC TITANIUM DIOXIDE XANTHAN GUM WHITE TO OFF-WHITE ROUND ZF29 olanzapine olanzapine OLANZAPINE OLANZAPINE CROSPOVIDONE HYPROMELLOSES LACTOSE MONOHYDRATE LECITHIN, SOYBEAN MAGNESIUM STEARATE TALC TITANIUM DIOXIDE XANTHAN GUM WHITE TO OFF-WHITE ROUND ZF30 olanzapine olanzapine OLANZAPINE OLANZAPINE HYPROMELLOSES LACTOSE MONOHYDRATE LECITHIN, SOYBEAN MAGNESIUM STEARATE TALC TITANIUM DIOXIDE XANTHAN GUM CROSPOVIDONE WHITE TO OFF-WHITE ROUND ZF31 olanzapine olanzapine OLANZAPINE OLANZAPINE CROSPOVIDONE HYPROMELLOSES LACTOSE MONOHYDRATE LECITHIN, SOYBEAN MAGNESIUM STEARATE TALC TITANIUM DIOXIDE XANTHAN GUM WHITE TO OFF-WHITE ELLIPTICAL-SHAPED ZF32 olanzapine olanzapine OLANZAPINE OLANZAPINE CROSPOVIDONE HYPROMELLOSES LACTOSE MONOHYDRATE LECITHIN, SOYBEAN MAGNESIUM STEARATE TALC TITANIUM DIOXIDE XANTHAN GUM WHITE TO OFF-WHITE ELLIPTICAL-SHAPED ZF33

Application Number

ANDA090459

Brand Name

Olanzapine

Generic Name

olanzapine

Product Ndc

70771-1421

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1416-0 in bottle of 1,000 tablets Olanzapine Tablets USP, 2.5 mg Rx only 1,000 tablets NDC 70771-1417-0 in bottle of 1,000 tablets Olanzapine Tablets USP, 5 mg Rx only 1,000 tablets NDC 70771-1418-0 in bottle of 1,000 tablets Olanzapine Tablets USP, 7.5 mg Rx only 1,000 tablets NDC 70771-1419-0 in bottle of 1,000 tablets Olanzapine Tablets USP, 10 mg Rx only 1,000 tablets NDC 70771-1420-0 in bottle of 1,000 tablets Olanzapine Tablets USP, 15 mg Rx only 1,000 tablets NDC 70771-1421-0 in bottle of 1,000 tablets Olanzapine Tablets USP, 20 mg Rx only 1,000 tablets 2.5 mg label 5 mg label 7.5 mg label 10 mg label 15 mg label 20 mg label

Spl Medguide

SPL MEDGUIDE

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