Paroxetine
These highlights do not include all the information needed to use PAROXETINE ORAL SUSPENSION safely and effectively. See full prescribing information for PAROXETINE ORAL SUSPENSION. PAROXETINE oral suspension Initial U.S. Approval: 1992
Approved
Approval ID
134e76f0-45cf-47eb-b6e1-cdb3bb522a0a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 17, 2023
Manufacturers
FDA
ANI Pharmaceuticals, Inc.
DUNS: 145588013
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Paroxetine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70954-319
Application NumberANDA215003
Product Classification
M
Marketing Category
C73584
G
Generic Name
Paroxetine
Product Specifications
Route of AdministrationORAL
Effective DateOctober 17, 2023
FDA Product Classification
INGREDIENTS (16)
PAROXETINE HYDROCHLORIDE HEMIHYDRATEActive
Quantity: 10 mg in 5 mL
Code: X2ELS050D8
Classification: ACTIM
POLACRILIN POTASSIUMInactive
Code: 0BZ5A00FQU
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
SACCHARIN SODIUM MONOHYDRATEInactive
Code: A9CO00M9HV
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT