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FDA Approval

Trimipramine Maleate

CompanyEpic Pharma, LLC (DUNS: 827915443)

Effective Date

March 16, 2021

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

7162-RP(100 mg in 1 1)

Registrants (1)

Elite Laboratories, Inc.

DUNS Number

785398728

Manufacturing Establishments (1)

Elite Laboratories, Inc.

Labeler

Epic Pharma, LLC

Registrant

Elite Laboratories, Inc.

DUNS Number

785398728

Products (3)

Trimipramine Maleate

NDC Product Code

42806-804

Application Number

ANDA077361

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

March 16, 2021

Ingredients

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

Code: 269K6498LDClass: ACTIMQuantity: 100 mg in 1 1

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQKClass: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3Class: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

Trimipramine Maleate

NDC Product Code

42806-803

Application Number

ANDA077361

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

March 16, 2021

Ingredients

Code: 269K6498LDClass: ACTIMQuantity: 50 mg in 1 1

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQKClass: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3Class: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

Trimipramine Maleate

NDC Product Code

42806-802

Application Number

ANDA077361

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

March 16, 2021

Ingredients

Code: 269K6498LDClass: ACTIMQuantity: 25 mg in 1 1

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

Gelatin, UnspecifiedInactive

Code: 2G86QN327LClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQKClass: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3Class: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

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