Basic Information
Paroxetine
65862-154
Regulatory Information
65862-154
ANDA078406
C73584
September 8, 2023
USA
These highlights do not include all the information needed to use PAROXETINE TABLETS safely and effectively. See full prescribing information for PAROXETINE TABLETS. PAROXETINE tablets, for oral use Initial U.S. Approval: 1992
Human Prescription Drug Label
21
Company Information
650082092
Active Ingredients
LACTOSE MONOHYDRATE
Code: EWQ57Q8I5X
Class Code: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
Code: O7TSZ97GEP
Class Code: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO
Code: 5856J3G2A2
Class Code: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
Code: L11K75P92J
Class Code: IACT
MAGNESIUM STEARATE
Code: 70097M6I30
Class Code: IACT
TITANIUM DIOXIDE
Code: 15FIX9V2JP
Class Code: IACT
POLYETHYLENE GLYCOL 6000
Code: 30IQX730WE
Class Code: IACT
POLYSORBATE 80
Code: 6OZP39ZG8H
Class Code: IACT
HYPROMELLOSE 2910 (6 MPA.S)
Code: 0WZ8WG20P6
Class Code: IACT
D&C YELLOW NO. 10
Code: 35SW5USQ3G
Class Code: IACT
FD&C YELLOW NO. 6
Code: H77VEI93A8
Class Code: IACT
Active Moieties
PAROXETINE
Code: 41VRH5220H