Desipramine Hydrochloride

Manufacturing Establishments (1)

Amneal Pharmaceuticals Private Limited

Labeler

Amneal Pharmaceuticals NY LLC

DUNS Number

650762060

Products (6)

NDC Product Code

69238-1055

Application Number

ANDA208105

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

March 15, 2023

Ingredients

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

DesipramineActive

Code: 1Y58DO4MY1Class: ACTIBQuantity: 25 mg in 1 1

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671PClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

Desipramine Hydrochloride

NDC Product Code

69238-1063

Application Number

ANDA208105

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

March 15, 2023

Ingredients

DesipramineActive

Code: 1Y58DO4MY1Class: ACTIBQuantity: 150 mg in 1 1

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671PClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

Desipramine Hydrochloride

NDC Product Code

69238-1059

Application Number

ANDA208105

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

March 15, 2023

Ingredients

DesipramineActive

Code: 1Y58DO4MY1Class: ACTIBQuantity: 75 mg in 1 1

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

D&C RED NO. 27Inactive

Code: 2LRS185U6KClass: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671PClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

Desipramine Hydrochloride

NDC Product Code

69238-1057

Application Number

ANDA208105

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

March 15, 2023

Ingredients

DesipramineActive

Code: 1Y58DO4MY1Class: ACTIBQuantity: 50 mg in 1 1

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671PClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

Desipramine Hydrochloride

NDC Product Code

69238-1053

Application Number

ANDA208105

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

March 15, 2023

Ingredients

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

DesipramineActive

Code: 1Y58DO4MY1Class: ACTIBQuantity: 10 mg in 1 1

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQKClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671PClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

Desipramine Hydrochloride

NDC Product Code

69238-1061

Application Number

ANDA208105

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

March 15, 2023

Ingredients

DesipramineActive

Code: 1Y58DO4MY1Class: ACTIBQuantity: 100 mg in 1 1

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671PClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

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Desipramine Hydrochloride

Manufacturing Establishments (1)

Products (6)

Desipramine Hydrochloride

Desipramine Hydrochloride

Desipramine Hydrochloride

Desipramine Hydrochloride

Desipramine Hydrochloride

Desipramine Hydrochloride