MedPath
FDA Approval

Paroxetine Hydrochloride

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Lannett Company, Inc.
DUNS: 006422406
Effective Date
August 22, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Paroxetine(25 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Lannett Company, Inc.

Lannett Company, Inc.

006422406

Products3

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Paroxetine Hydrochloride

Product Details

NDC Product Code
62175-471
Application Number
ANDA204744
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
October 4, 2021
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
ParoxetineActive
Code: X2ELS050D8Class: ACTIMQuantity: 25 mg in 1 1
HYPROMELLOSE 2208 (100 MPA.S)Inactive
Code: B1QE5P712KClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S)Inactive
Code: T967IEU43CClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
PIGMENT RED 48Inactive
Code: 07XHK4SAV6Class: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
POLYVINYL ALCOHOL (100000 MW)Inactive
Code: 949E52Z6MYClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UMClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT

Paroxetine Hydrochloride

Product Details

NDC Product Code
62175-472
Application Number
ANDA204744
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
October 4, 2021
ParoxetineActive
Code: X2ELS050D8Class: ACTIMQuantity: 37.5 mg in 1 1
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S)Inactive
Code: T967IEU43CClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYPROMELLOSE 2208 (100 MPA.S)Inactive
Code: B1QE5P712KClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
POLYVINYL ALCOHOL (100000 MW)Inactive
Code: 949E52Z6MYClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UMClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT

Paroxetine Hydrochloride

Product Details

NDC Product Code
62175-470
Application Number
ANDA204744
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
October 4, 2021
ParoxetineActive
Code: X2ELS050D8Class: ACTIMQuantity: 12.5 mg in 1 1
HYPROMELLOSE 2208 (100 MPA.S)Inactive
Code: B1QE5P712KClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S)Inactive
Code: T967IEU43CClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYVINYL ALCOHOL (100000 MW)Inactive
Code: 949E52Z6MYClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UMClass: IACT
© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy