Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
IntelliPharmaCeutics Corp.
255128878
Manufacturing Establishments2
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Zhejiang Supor Pharmaceuticals Co., Ltd.
SpecGx LLC
IntelliPharmaCeutics Corp.
528106094
IntelliPharmaCeutics Corp.
SpecGx LLC
IntelliPharmaCeutics Corp.
255128878
Products5
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Quetiapine Fumarate Extended-Release
Product Details
NDC Product Code
0406-1181Application Number
ANDA202939Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
February 5, 2014QuetiapineActive
Code: 2S3PL1B6UJClass: ACTIMQuantity: 150 mg in 1 1
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
ETHYLCELLULOSE (100 MPA.S)Inactive
Code: 47MLB0F1MVClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)Inactive
Code: ZYD53NBL45Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
Quetiapine Fumarate Extended-Release
Product Details
NDC Product Code
0406-1184Application Number
ANDA202939Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
February 5, 2014ETHYLCELLULOSE (100 MPA.S)Inactive
Code: 47MLB0F1MVClass: IACT
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)Inactive
Code: ZYD53NBL45Class: IACT
QuetiapineActive
Code: 2S3PL1B6UJClass: ACTIMQuantity: 400 mg in 1 1
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
Quetiapine Fumarate Extended-Release
Product Details
NDC Product Code
0406-1183Application Number
ANDA202939Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
February 5, 2014QuetiapineActive
Code: 2S3PL1B6UJClass: ACTIMQuantity: 300 mg in 1 1
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
ETHYLCELLULOSE (100 MPA.S)Inactive
Code: 47MLB0F1MVClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IEClass: IACT
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)Inactive
Code: ZYD53NBL45Class: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
Quetiapine Fumarate Extended-Release
Product Details
NDC Product Code
0406-1182Application Number
ANDA202939Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
February 5, 2014HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)Inactive
Code: ZYD53NBL45Class: IACT
ETHYLCELLULOSE (100 MPA.S)Inactive
Code: 47MLB0F1MVClass: IACT
QuetiapineActive
Code: 2S3PL1B6UJClass: ACTIMQuantity: 200 mg in 1 1
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IEClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
Quetiapine Fumarate Extended-Release
Product Details
NDC Product Code
0406-1180Application Number
ANDA202939Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
February 5, 2014QuetiapineActive
Code: 2S3PL1B6UJClass: ACTIMQuantity: 50 mg in 1 1
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
ETHYLCELLULOSE (100 MPA.S)Inactive
Code: 47MLB0F1MVClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)Inactive
Code: ZYD53NBL45Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT