Paroxetine
Paroxetine Tablets USP, film coated for oral use
Approved
Approval ID
6cfde064-ddcb-49df-a53c-953c40eb1470
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 24, 2020
Manufacturers
FDA
Solco Healthcare US, LLC
DUNS: 828343017
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
paroxetine hydrochloride hemihydrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43547-350
Application NumberANDA203854
Product Classification
M
Marketing Category
C73584
G
Generic Name
paroxetine hydrochloride hemihydrate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 25, 2018
FDA Product Classification
INGREDIENTS (9)
PAROXETINE HYDROCHLORIDE HEMIHYDRATEActive
Quantity: 40 mg in 1 1
Code: X2ELS050D8
Classification: ACTIM
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
GLYCERYL DIBEHENATEInactive
Code: R8WTH25YS2
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
paroxetine hydrochloride hemihydrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43547-349
Application NumberANDA203854
Product Classification
M
Marketing Category
C73584
G
Generic Name
paroxetine hydrochloride hemihydrate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 25, 2018
FDA Product Classification
INGREDIENTS (9)
PAROXETINE HYDROCHLORIDE HEMIHYDRATEActive
Quantity: 30 mg in 1 1
Code: X2ELS050D8
Classification: ACTIM
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
GLYCERYL DIBEHENATEInactive
Code: R8WTH25YS2
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
paroxetine hydrochloride hemihydrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43547-347
Application NumberANDA203854
Product Classification
M
Marketing Category
C73584
G
Generic Name
paroxetine hydrochloride hemihydrate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 25, 2018
FDA Product Classification
INGREDIENTS (9)
PAROXETINE HYDROCHLORIDE HEMIHYDRATEActive
Quantity: 10 mg in 1 1
Code: X2ELS050D8
Classification: ACTIM
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
GLYCERYL DIBEHENATEInactive
Code: R8WTH25YS2
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
paroxetine hydrochloride hemihydrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43547-348
Application NumberANDA203854
Product Classification
M
Marketing Category
C73584
G
Generic Name
paroxetine hydrochloride hemihydrate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 25, 2018
FDA Product Classification
INGREDIENTS (9)
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
PAROXETINE HYDROCHLORIDE HEMIHYDRATEActive
Quantity: 20 mg in 1 1
Code: X2ELS050D8
Classification: ACTIM
GLYCERYL DIBEHENATEInactive
Code: R8WTH25YS2
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT