PAXIL

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Apotex Inc.

DUNS Number

205576023

Products6

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

PAXIL CR

Product Details

NDC Product Code

60505-3670

Application Number

NDA020936

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

January 10, 2024

Ingredients

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

ParoxetineActive

Code: X2ELS050D8Class: ACTIMQuantity: 37.5 mg in 1 1

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

GLYCERYL DIBEHENATEInactive

Code: R8WTH25YS2Class: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8HClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UMClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQKClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

POLYETHYLENE GLYCOL 10000Inactive

Code: H57W405143Class: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive

Code: NX76LV5T8JClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

PAXIL CR

Product Details

NDC Product Code

60505-3669

Application Number

NDA020936

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

January 10, 2024

Ingredients

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

ParoxetineActive

Code: X2ELS050D8Class: ACTIMQuantity: 25 mg in 1 1

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

GLYCERYL DIBEHENATEInactive

Code: R8WTH25YS2Class: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive

Code: NX76LV5T8JClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8HClass: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UMClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

POLYETHYLENE GLYCOL 10000Inactive

Code: H57W405143Class: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQKClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

PAXIL CR

Product Details

NDC Product Code

60505-3668

Application Number

NDA020936

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

January 10, 2024

Ingredients

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

ParoxetineActive

Code: X2ELS050D8Class: ACTIMQuantity: 12.5 mg in 1 1

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

GLYCERYL DIBEHENATEInactive

Code: R8WTH25YS2Class: IACT

METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive

Code: NX76LV5T8JClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UMClass: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8HClass: IACT

POLYETHYLENE GLYCOL 10000Inactive

Code: H57W405143Class: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQKClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

PAXIL CR

Product Details

NDC Product Code

60505-4379

Application Number

NDA020936

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

January 10, 2024

Ingredients

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

GLYCERYL DIBEHENATEInactive

Code: R8WTH25YS2Class: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8HClass: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQKClass: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UMClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

ParoxetineActive

Code: X2ELS050D8Class: ACTIMQuantity: 37.5 mg in 1 1

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive

Code: NX76LV5T8JClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

POLYETHYLENE GLYCOL 10000Inactive

Code: H57W405143Class: IACT

PAXIL CR

Product Details

NDC Product Code

60505-4377

Application Number

NDA020936

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

January 10, 2024

Ingredients

ParoxetineActive

Code: X2ELS050D8Class: ACTIMQuantity: 12.5 mg in 1 1

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

GLYCERYL DIBEHENATEInactive

Code: R8WTH25YS2Class: IACT

METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive

Code: NX76LV5T8JClass: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8HClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UMClass: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

POLYETHYLENE GLYCOL 10000Inactive

Code: H57W405143Class: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

PAXIL CR

Product Details

NDC Product Code

60505-4378

Application Number

NDA020936

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

January 10, 2024

Ingredients

ParoxetineActive

Code: X2ELS050D8Class: ACTIMQuantity: 25 mg in 1 1

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UMClass: IACT

POLYETHYLENE GLYCOL 10000Inactive

Code: H57W405143Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive

Code: NX76LV5T8JClass: IACT

D&C RED NO. 30Inactive

Code: 2S42T2808BClass: IACT

GLYCERYL DIBEHENATEInactive

Code: R8WTH25YS2Class: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8HClass: IACT

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FDA Approval Summary

Registrants1

Products6

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Product Details

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Product Details

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Product Details

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Product Details