DESIPRAMINE HYDROCHLORIDE

Manufacturing Establishments (1)

Alembic Pharmaceuticals Limited

Labeler

Alembic Pharmaceuticals Inc.

DUNS Number

650574671

Products (6)

NDC Product Code

62332-320

Application Number

ANDA209785

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

October 12, 2021

Ingredients

DesipramineActive

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

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive

Code: UKE75GEA7FClass: IACT

CITRIC ACID MONOHYDRATEInactive

Code: 2968PHW8QPClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POLYETHYLENE GLYCOL 6000Inactive

Code: 30IQX730WEClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

DESIPRAMINE HYDROCHLORIDE

NDC Product Code

62332-318

Application Number

ANDA209785

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

October 12, 2021

Ingredients

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

DesipramineActive

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

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

CITRIC ACID MONOHYDRATEInactive

Code: 2968PHW8QPClass: IACT

POLYETHYLENE GLYCOL 8000Inactive

Code: Q662QK8M3BClass: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive

Code: UKE75GEA7FClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

DESIPRAMINE HYDROCHLORIDE

NDC Product Code

62332-315

Application Number

ANDA209785

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

October 12, 2021

Ingredients

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

CITRIC ACID MONOHYDRATEInactive

Code: 2968PHW8QPClass: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

DesipramineActive

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

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive

Code: UKE75GEA7FClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POLYETHYLENE GLYCOL 8000Inactive

Code: Q662QK8M3BClass: IACT

DESIPRAMINE HYDROCHLORIDE

NDC Product Code

62332-316

Application Number

ANDA209785

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

October 12, 2021

Ingredients

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

CITRIC ACID MONOHYDRATEInactive

Code: 2968PHW8QPClass: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

DesipramineActive

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

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQKClass: IACT

D&C YELLOW NO. 10 ALUMINUM LAKEInactive

Code: CQ3XH3DET6Class: IACT

HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive

Code: UKE75GEA7FClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POLYETHYLENE GLYCOL 8000Inactive

Code: Q662QK8M3BClass: IACT

DESIPRAMINE HYDROCHLORIDE

NDC Product Code

62332-319

Application Number

ANDA209785

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

October 12, 2021

Ingredients

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

DesipramineActive

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

HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive

Code: UKE75GEA7FClass: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

CITRIC ACID MONOHYDRATEInactive

Code: 2968PHW8QPClass: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POLYETHYLENE GLYCOL 8000Inactive

Code: Q662QK8M3BClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQKClass: IACT

D&C YELLOW NO. 10 ALUMINUM LAKEInactive

Code: CQ3XH3DET6Class: IACT

DESIPRAMINE HYDROCHLORIDE

NDC Product Code

62332-317

Application Number

ANDA209785

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

October 12, 2021

Ingredients

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

DesipramineActive

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

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive

Code: UKE75GEA7FClass: IACT

CITRIC ACID MONOHYDRATEInactive

Code: 2968PHW8QPClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POLYETHYLENE GLYCOL 8000Inactive

Code: Q662QK8M3BClass: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

D&C YELLOW NO. 10 ALUMINUM LAKEInactive

Code: CQ3XH3DET6Class: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

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DESIPRAMINE HYDROCHLORIDE

Manufacturing Establishments (1)

Products (6)

DESIPRAMINE HYDROCHLORIDE

DESIPRAMINE HYDROCHLORIDE

DESIPRAMINE HYDROCHLORIDE

DESIPRAMINE HYDROCHLORIDE

DESIPRAMINE HYDROCHLORIDE

DESIPRAMINE HYDROCHLORIDE