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FDA Approval

Quetiapine fumarate

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

FDA Approval Summary

Company

Lupin Pharmaceuticals, Inc.

DUNS: 089153071

Effective Date

December 15, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Quetiapine(150 mg in 1 1)

Registrants1

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

DUNS Number

675923163

Manufacturing Establishments1

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

Labeler

Lupin Pharmaceuticals, Inc.

Registrant

LUPIN LIMITED

DUNS Number

863645527

Products5

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

Quetiapine fumarate

Product Details

NDC Product Code

68180-613

Application Number

ANDA204203

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 15, 2023

Ingredients

QuetiapineActive

Code: 2S3PL1B6UJClass: ACTIMQuantity: 150 mg in 1 1

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

TRISODIUM CITRATE DIHYDRATEInactive

Code: B22547B95KClass: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

HYPROMELLOSE 2910 (15000 MPA.S)Inactive

Code: 288VBX44JCClass: IACT

HYPROMELLOSE 2208 (15000 MPA.S)Inactive

Code: Z78RG6M2N2Class: IACT

Quetiapine fumarate

Product Details

NDC Product Code

68180-616

Application Number

ANDA204203

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 15, 2023

Ingredients

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

QuetiapineActive

Code: 2S3PL1B6UJClass: ACTIMQuantity: 400 mg in 1 1

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

HYPROMELLOSE 2208 (15000 MPA.S)Inactive

Code: Z78RG6M2N2Class: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6Class: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

TRISODIUM CITRATE DIHYDRATEInactive

Code: B22547B95KClass: IACT

Quetiapine fumarate

Product Details

NDC Product Code

68180-614

Application Number

ANDA204203

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 15, 2023

Ingredients

QuetiapineActive

Code: 2S3PL1B6UJClass: ACTIMQuantity: 200 mg in 1 1

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

HYPROMELLOSE 2208 (15000 MPA.S)Inactive

Code: Z78RG6M2N2Class: IACT

HYPROMELLOSE 2910 (15000 MPA.S)Inactive

Code: 288VBX44JCClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

TRISODIUM CITRATE DIHYDRATEInactive

Code: B22547B95KClass: IACT

Quetiapine fumarate

Product Details

NDC Product Code

68180-615

Application Number

ANDA204203

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 15, 2023

Ingredients

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

QuetiapineActive

Code: 2S3PL1B6UJClass: ACTIMQuantity: 300 mg in 1 1

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

HYPROMELLOSE 2208 (15000 MPA.S)Inactive

Code: Z78RG6M2N2Class: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6Class: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQClass: IACT

TRISODIUM CITRATE DIHYDRATEInactive

Code: B22547B95KClass: IACT

Quetiapine fumarate

Product Details

NDC Product Code

68180-612

Application Number

ANDA204203

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 15, 2023

Ingredients

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6Class: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

TRISODIUM CITRATE DIHYDRATEInactive

Code: B22547B95KClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

QuetiapineActive

Code: 2S3PL1B6UJClass: ACTIMQuantity: 50 mg in 1 1

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

HYPROMELLOSE 2208 (15000 MPA.S)Inactive

Code: Z78RG6M2N2Class: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQClass: IACT

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