Basic Information
Quetiapine Fumarate
71335-0926
Regulatory Information
71335-0926
ANDA201504
C73584
November 3, 2023
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
16
Company Information
171714327
Active Ingredients
Inactive Ingredients
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
Code: O7TSZ97GEP
Class Code: IACT
MICROCRYSTALLINE CELLULOSE
Code: OP1R32D61U
Class Code: IACT
LACTOSE MONOHYDRATE
Code: EWQ57Q8I5X
Class Code: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO
Code: 5856J3G2A2
Class Code: IACT
POVIDONE K30
Code: U725QWY32X
Class Code: IACT
MAGNESIUM STEARATE
Code: 70097M6I30
Class Code: IACT
HYPROMELLOSE 2910 (5 MPA.S)
Code: R75537T0T4
Class Code: IACT
POLYETHYLENE GLYCOL 400
Code: B697894SGQ
Class Code: IACT
TITANIUM DIOXIDE
Code: 15FIX9V2JP
Class Code: IACT
Active Moieties
QUETIAPINE
Code: BGL0JSY5SI