Basic Information
SERTRALINE HYDROCHLORIDE
71335-1078
Regulatory Information
71335-1078
ANDA202825
C73584
January 5, 2024
USA
These highlights do not include all the information needed to use SERTRALINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SERTRALINE HYDROCHLORIDE TABLETS. SERTRALINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1991
HUMAN PRESCRIPTION DRUG LABEL
102
Company Information
171714327
Active Ingredients
MICROCRYSTALLINE CELLULOSE
Code: OP1R32D61U
Class Code: IACT
MAGNESIUM STEARATE
Code: 70097M6I30
Class Code: IACT
HYPROMELLOSE 2910 (5 MPA.S)
Code: R75537T0T4
Class Code: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
Code: L11K75P92J
Class Code: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO
Code: 5856J3G2A2
Class Code: IACT
POLYETHYLENE GLYCOL 400
Code: B697894SGQ
Class Code: IACT
TITANIUM DIOXIDE
Code: 15FIX9V2JP
Class Code: IACT
D&C YELLOW NO. 10
Code: 35SW5USQ3G
Class Code: IACT
POLYSORBATE 80
Code: 6OZP39ZG8H
Class Code: IACT
FD&C BLUE NO. 1
Code: H3R47K3TBD
Class Code: IACT
HYDROXYPROPYL CELLULOSE (90000 WAMW)
Code: UKE75GEA7F
Class Code: IACT
Active Moieties
SERTRALINE
Code: QUC7NX6WMB