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FDA Approval

Quetiapine

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

FDA Approval Summary

Company
Northstar RxLLC
DUNS: 830546433
Effective Date
December 2, 2022
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Quetiapine(200 mg in 1 1)

Manufacturing Establishments1

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

Intas Pharmaceuticals Limited

Northstar RxLLC

915837971

Products6

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

Quetiapine

Product Details

NDC Product Code
16714-455
Application Number
ANDA202152
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
December 2, 2022
POVIDONEInactive
Code: FZ989GH94EClass: IACT
QuetiapineActive
Code: 2S3PL1B6UJClass: ACTIMQuantity: 200 mg in 1 1
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEPClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4Class: IACT

Quetiapine

Product Details

NDC Product Code
16714-453
Application Number
ANDA202152
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
December 2, 2022
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEPClass: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4Class: IACT
QuetiapineActive
Code: 2S3PL1B6UJClass: ACTIMQuantity: 50 mg in 1 1

Quetiapine

Product Details

NDC Product Code
16714-456
Application Number
ANDA202152
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
December 2, 2022
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEPClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4Class: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
QuetiapineActive
Code: 2S3PL1B6UJClass: ACTIMQuantity: 300 mg in 1 1
POVIDONEInactive
Code: FZ989GH94EClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT

Quetiapine

Product Details

NDC Product Code
16714-454
Application Number
ANDA202152
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
December 2, 2022
POVIDONEInactive
Code: FZ989GH94EClass: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEPClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
QuetiapineActive
Code: 2S3PL1B6UJClass: ACTIMQuantity: 100 mg in 1 1
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT

Quetiapine

Product Details

NDC Product Code
16714-457
Application Number
ANDA202152
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
December 2, 2022
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEPClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
QuetiapineActive
Code: 2S3PL1B6UJClass: ACTIMQuantity: 400 mg in 1 1
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT

Quetiapine

Product Details

NDC Product Code
16714-452
Application Number
ANDA202152
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
December 2, 2022
POVIDONEInactive
Code: FZ989GH94EClass: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEPClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
QuetiapineActive
Code: 2S3PL1B6UJClass: ACTIMQuantity: 25 mg in 1 1
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
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