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FDA Approval

Doxepin Hydrochloride

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company

Novadoz Pharmaceuticals LLC

DUNS: 081109687

Effective Date

June 22, 2022

Labeling Type

Human Prescription Drug Label

Active Ingredients

Doxepin(25 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

MSN LABORATORIES PRIVATE LIMITED

Labeler

Novadoz Pharmaceuticals LLC

DUNS Number

650786952

Products5

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Doxepin Hydrochloride

Product Details

NDC Product Code

72205-089

Application Number

ANDA215113

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 2, 2020

Ingredients

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

Code: 3U9A0FE9N5Class: ACTIMQuantity: 25 mg in 1 1

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

SHELLACInactive

Code: MB5IUD6JUAClass: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

Doxepin Hydrochloride

Product Details

NDC Product Code

72205-091

Application Number

ANDA215113

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 2, 2020

Ingredients

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

SHELLACInactive

Code: MB5IUD6JUAClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

FD&C GREEN NO. 3Inactive

Code: 3P3ONR6O1SClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

Code: 3U9A0FE9N5Class: ACTIMQuantity: 75 mg in 1 1

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

Doxepin Hydrochloride

Product Details

NDC Product Code

72205-088

Application Number

ANDA215113

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 2, 2020

Ingredients

GELATINInactive

Code: 2G86QN327LClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

Code: 3U9A0FE9N5Class: ACTIMQuantity: 10 mg in 1 1

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

SHELLACInactive

Code: MB5IUD6JUAClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

Doxepin Hydrochloride

Product Details

NDC Product Code

72205-092

Application Number

ANDA215113

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 2, 2020

Ingredients

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

Code: 3U9A0FE9N5Class: ACTIMQuantity: 100 mg in 1 1

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

SHELLACInactive

Code: MB5IUD6JUAClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

FD&C GREEN NO. 3Inactive

Code: 3P3ONR6O1SClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

Doxepin Hydrochloride

Product Details

NDC Product Code

72205-090

Application Number

ANDA215113

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 2, 2020

Ingredients

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

Code: 3U9A0FE9N5Class: ACTIMQuantity: 50 mg in 1 1

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

SHELLACInactive

Code: MB5IUD6JUAClass: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

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