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FDA Approval

DESIPRAMINE HYDROCHLORIDE

CompanyIngenus Pharmaceuticals, LLC (DUNS: 833250017)

Effective Date

June 22, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Desipramine(25 mg in 1 1)

Registrants (1)

Novast Laboratories , Ltd.

DUNS Number

527695995

Manufacturing Establishments (1)

Ingenus Pharmaceuticals NJ, LLC

Labeler

Ingenus Pharmaceuticals, LLC

Registrant

Novast Laboratories , Ltd.

DUNS Number

964680206

Products (6)

DESIPRAMINE HYDROCHLORIDE

NDC Product Code

50742-113

Application Number

ANDA204963

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

June 22, 2023

Ingredients

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQClass: IACT

DesipramineActive

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

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

DESIPRAMINE HYDROCHLORIDE

NDC Product Code

50742-115

Application Number

ANDA204963

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

June 22, 2023

Ingredients

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQClass: IACT

DesipramineActive

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

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

DESIPRAMINE HYDROCHLORIDE

NDC Product Code

50742-116

Application Number

ANDA204963

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

June 22, 2023

Ingredients

DesipramineActive

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

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

DESIPRAMINE HYDROCHLORIDE

NDC Product Code

50742-112

Application Number

ANDA204963

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

June 22, 2023

Ingredients

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQClass: IACT

DesipramineActive

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

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

DESIPRAMINE HYDROCHLORIDE

NDC Product Code

50742-117

Application Number

ANDA204963

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

June 22, 2023

Ingredients

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQClass: IACT

DesipramineActive

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

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

DESIPRAMINE HYDROCHLORIDE

NDC Product Code

50742-114

Application Number

ANDA204963

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

June 22, 2023

Ingredients

DesipramineActive

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

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQClass: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

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