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FDA Approval

Desipramine Hydrochloride

CompanyINDICUS PHARMA LLC (DUNS: 793870606)

Effective Date

July 21, 2016

Labeling Type

Human Prescription Drug Label

Active Ingredients

Desipramine(100 mg in 1 1)

Manufacturing Establishments (1)

USV Private Limited, Daman

Labeler

INDICUS PHARMA LLC

DUNS Number

650434348

Products (6)

Desipramine Hydrochloride

NDC Product Code

24724-071

Application Number

ANDA207433

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

July 21, 2016

Ingredients

DesipramineActive

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

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6Class: IACT

POLYETHYLENE GLYCOL 8000Inactive

Code: Q662QK8M3BClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

Desipramine Hydrochloride

NDC Product Code

24724-070

Application Number

ANDA207433

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

July 21, 2016

Ingredients

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

DesipramineActive

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

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

POLYETHYLENE GLYCOL 8000Inactive

Code: Q662QK8M3BClass: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6Class: IACT

Desipramine Hydrochloride

NDC Product Code

24724-072

Application Number

ANDA207433

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

July 21, 2016

Ingredients

DesipramineActive

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

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

POLYETHYLENE GLYCOL 8000Inactive

Code: Q662QK8M3BClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

Desipramine Hydrochloride

NDC Product Code

24724-068

Application Number

ANDA207433

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

July 21, 2016

Ingredients

DesipramineActive

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

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6Class: IACT

POLYETHYLENE GLYCOL 8000Inactive

Code: Q662QK8M3BClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

Desipramine Hydrochloride

NDC Product Code

24724-067

Application Number

ANDA207433

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

July 21, 2016

Ingredients

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

POLYETHYLENE GLYCOL 8000Inactive

Code: Q662QK8M3BClass: IACT

DesipramineActive

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

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

Desipramine Hydrochloride

NDC Product Code

24724-069

Application Number

ANDA207433

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

July 21, 2016

Ingredients

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

DesipramineActive

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

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

POLYETHYLENE GLYCOL 8000Inactive

Code: Q662QK8M3BClass: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

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