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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

JUBILANT CADISTA PHARMACEUTICALS INC.

DUNS: 022490515

Effective Date

September 1, 2021

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Doxepin(50 mg in 1 1)

Manufacturing Establishments1

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

JUBILANT CADISTA PHARMACEUTICALS INC.

Labeler

JUBILANT CADISTA PHARMACEUTICALS INC.

DUNS Number

022490515

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

59746-702

Application Number

ANDA215483

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 13, 2021

Ingredients

Propylene GlycolInactive

Code: 6DC9Q167V3Class: IACT

Ferrosoferric OxideInactive

Code: XM0M87F357Class: IACT

Ferric Oxide YellowInactive

Code: EX438O2MRTClass: IACT

Starch, CornInactive

Code: O8232NY3SJClass: IACT

Silicon DioxideInactive

Code: ETJ7Z6XBU4Class: IACT

Microcrystalline CelluloseInactive

Code: OP1R32D61UClass: IACT

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

Magnesium StearateInactive

Code: 70097M6I30Class: IACT

Sodium Lauryl SulfateInactive

Code: 368GB5141JClass: IACT

Potassium HydroxideInactive

Code: WZH3C48M4TClass: IACT

Gelatin, UnspecifiedInactive

Code: 2G86QN327LClass: IACT

Titanium DioxideInactive

Code: 15FIX9V2JPClass: IACT

ShellacInactive

Code: 46N107B71OClass: IACT

Doxepin Hydrochloride

Product Details

NDC Product Code

59746-701

Application Number

ANDA215483

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 13, 2021

Ingredients

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

Silicon DioxideInactive

Code: ETJ7Z6XBU4Class: IACT

Magnesium StearateInactive

Code: 70097M6I30Class: IACT

Microcrystalline CelluloseInactive

Code: OP1R32D61UClass: IACT

Sodium Lauryl SulfateInactive

Code: 368GB5141JClass: IACT

Starch, CornInactive

Code: O8232NY3SJClass: IACT

Gelatin, UnspecifiedInactive

Code: 2G86QN327LClass: IACT

Potassium HydroxideInactive

Code: WZH3C48M4TClass: IACT

Titanium DioxideInactive

Code: 15FIX9V2JPClass: IACT

Ferric Oxide YellowInactive

Code: EX438O2MRTClass: IACT

Ferrosoferric OxideInactive

Code: XM0M87F357Class: IACT

Propylene GlycolInactive

Code: 6DC9Q167V3Class: IACT

ShellacInactive

Code: 46N107B71OClass: IACT

Doxepin Hydrochloride

Product Details

NDC Product Code

59746-700

Application Number

ANDA215483

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 13, 2021

Ingredients

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

Magnesium StearateInactive

Code: 70097M6I30Class: IACT

Microcrystalline CelluloseInactive

Code: OP1R32D61UClass: IACT

Sodium Lauryl SulfateInactive

Code: 368GB5141JClass: IACT

Ferrosoferric OxideInactive

Code: XM0M87F357Class: IACT

Starch, CornInactive

Code: O8232NY3SJClass: IACT

Titanium DioxideInactive

Code: 15FIX9V2JPClass: IACT

Potassium HydroxideInactive

Code: WZH3C48M4TClass: IACT

Propylene GlycolInactive

Code: 6DC9Q167V3Class: IACT

ShellacInactive

Code: 46N107B71OClass: IACT

Silicon DioxideInactive

Code: ETJ7Z6XBU4Class: IACT

Gelatin, UnspecifiedInactive

Code: 2G86QN327LClass: IACT

Doxepin Hydrochloride

Product Details

NDC Product Code

59746-704

Application Number

ANDA215483

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 13, 2021

Ingredients

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

Magnesium StearateInactive

Code: 70097M6I30Class: IACT

Microcrystalline CelluloseInactive

Code: OP1R32D61UClass: IACT

Silicon DioxideInactive

Code: ETJ7Z6XBU4Class: IACT

Starch, CornInactive

Code: O8232NY3SJClass: IACT

Gelatin, UnspecifiedInactive

Code: 2G86QN327LClass: IACT

Sodium Lauryl SulfateInactive

Code: 368GB5141JClass: IACT

Titanium DioxideInactive

Code: 15FIX9V2JPClass: IACT

Ferrosoferric OxideInactive

Code: XM0M87F357Class: IACT

Ferric Oxide YellowInactive

Code: EX438O2MRTClass: IACT

Fd&C Blue No. 1Inactive

Code: H3R47K3TBDClass: IACT

ShellacInactive

Code: 46N107B71OClass: IACT

Potassium HydroxideInactive

Code: WZH3C48M4TClass: IACT

Propylene GlycolInactive

Code: 6DC9Q167V3Class: IACT

Doxepin Hydrochloride

Product Details

NDC Product Code

59746-703

Application Number

ANDA215483

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 13, 2021

Ingredients

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

Magnesium StearateInactive

Code: 70097M6I30Class: IACT

Starch, CornInactive

Code: O8232NY3SJClass: IACT

Sodium Lauryl SulfateInactive

Code: 368GB5141JClass: IACT

Silicon DioxideInactive

Code: ETJ7Z6XBU4Class: IACT

Gelatin, UnspecifiedInactive

Code: 2G86QN327LClass: IACT

Titanium DioxideInactive

Code: 15FIX9V2JPClass: IACT

Potassium HydroxideInactive

Code: WZH3C48M4TClass: IACT

Fd&C Blue No. 1Inactive

Code: H3R47K3TBDClass: IACT

ShellacInactive

Code: 46N107B71OClass: IACT

Propylene GlycolInactive

Code: 6DC9Q167V3Class: IACT

Microcrystalline CelluloseInactive

Code: OP1R32D61UClass: IACT

Ferrosoferric OxideInactive

Code: XM0M87F357Class: IACT

Ferric Oxide YellowInactive

Code: EX438O2MRTClass: IACT

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