Products3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Paroxetine
Product Details
NDC Product Code
62135-425Application Number
ANDA204744Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 13, 2022METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S)Inactive
Code: T967IEU43CClass: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UMClass: IACT
HYPROMELLOSE 2208 (100 MPA.S)Inactive
Code: B1QE5P712KClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
POLYVINYL ALCOHOL (100000 MW)Inactive
Code: 949E52Z6MYClass: IACT
ParoxetineActive
Code: X2ELS050D8Class: ACTIMQuantity: 12.5 mg in 1 1
Paroxetine
Product Details
NDC Product Code
62135-426Application Number
ANDA204744Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 13, 2022FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
PIGMENT RED 48Inactive
Code: 07XHK4SAV6Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UMClass: IACT
HYPROMELLOSE 2208 (100 MPA.S)Inactive
Code: B1QE5P712KClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S)Inactive
Code: T967IEU43CClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
POLYVINYL ALCOHOL (100000 MW)Inactive
Code: 949E52Z6MYClass: IACT
ParoxetineActive
Code: X2ELS050D8Class: ACTIMQuantity: 25 mg in 1 1
Paroxetine
Product Details
NDC Product Code
62135-427Application Number
ANDA204744Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 13, 2022FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
HYPROMELLOSE 2208 (100 MPA.S)Inactive
Code: B1QE5P712KClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S)Inactive
Code: T967IEU43CClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UMClass: IACT
ParoxetineActive
Code: X2ELS050D8Class: ACTIMQuantity: 37.5 mg in 1 1
POLYVINYL ALCOHOL (100000 MW)Inactive
Code: 949E52Z6MYClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT