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FDA Product

Quetiapine Fumarate

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Quetiapine Fumarate

53002-2529

Regulatory Information

53002-2529

ANDA201504

C73584

November 30, 2021

USA

These highlights do not include all the information needed to use QUETIAPINE TABLETS safely and effectively. See full prescribing information for QUETIAPINE TABLETS. QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997

Human Prescription Drug Label

2

Company Information

147096275

Active Ingredients

QUETIAPINE FUMARATE

Quantity: 50 mg in 1 1

Code: 2S3PL1B6UJ

Class Code: ACTIM

DIBASIC CALCIUM PHOSPHATE DIHYDRATE

Code: O7TSZ97GEP

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

POVIDONE K30

Code: U725QWY32X

Class Code: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATO

Code: 5856J3G2A2

Class Code: IACT

POLYETHYLENE GLYCOL 400

Code: B697894SGQ

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

HYPROMELLOSE 2910 (5 MPA.S)

Code: R75537T0T4

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

Active Moieties

QUETIAPINE

Code: BGL0JSY5SI

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