Basic Information
PAROXETINE HYDROCHLORIDE
60505-3675
Regulatory Information
60505-3675
NDA020936
C73594
September 29, 2023
USA
These highlights do not include all the information needed to use Paroxetine HCL CR safely and effectively. See full prescribing information for . (paroxetine) extended-release tablets, for oral use Initial U.S. Approval: 1992
HUMAN PRESCRIPTION DRUG LABEL
16
Company Information
845263701
Active Ingredients
HYPROMELLOSE, UNSPECIFIED
Code: 3NXW29V3WO
Class Code: IACT
POVIDONE K30
Code: U725QWY32X
Class Code: IACT
MAGNESIUM STEARATE
Code: 70097M6I30
Class Code: IACT
SILICON DIOXIDE
Code: ETJ7Z6XBU4
Class Code: IACT
LACTOSE MONOHYDRATE
Code: EWQ57Q8I5X
Class Code: IACT
GLYCERYL DIBEHENATE
Code: R8WTH25YS2
Class Code: IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER
Code: NX76LV5T8J
Class Code: IACT
TRIETHYL CITRATE
Code: 8Z96QXD6UM
Class Code: IACT
POLYSORBATE 80
Code: 6OZP39ZG8H
Class Code: IACT
TITANIUM DIOXIDE
Code: 15FIX9V2JP
Class Code: IACT
SODIUM LAURYL SULFATE
Code: 368GB5141J
Class Code: IACT
TALC
Code: 7SEV7J4R1U
Class Code: IACT
POLYETHYLENE GLYCOL 10000
Code: H57W405143
Class Code: IACT
FD&C BLUE NO. 2
Code: L06K8R7DQK
Class Code: IACT
FERRIC OXIDE YELLOW
Code: EX438O2MRT
Class Code: IACT
Active Moieties
PAROXETINE
Code: 41VRH5220H