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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

Ajanta Pharma USA Inc.

DUNS: 557554156

Effective Date

November 24, 2021

Labeling Type

Human Prescription Drug Label

Active Ingredients

Doxepin(75 mg in 1 1)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Ajanta Pharma Limited

DUNS Number

918594859

Manufacturing Establishments1

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

Ajanta Pharma Ltd., Dahej

Labeler

Ajanta Pharma USA Inc.

Registrant

Ajanta Pharma Limited

DUNS Number

862199968

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

27241-170

Application Number

ANDA212624

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

November 24, 2021

Ingredients

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

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

FD&C GREEN NO. 3Inactive

Code: 3P3ONR6O1SClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

Doxepin hydrochloride

Product Details

NDC Product Code

27241-171

Application Number

ANDA212624

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

November 24, 2021

Ingredients

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

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

FD&C GREEN NO. 3Inactive

Code: 3P3ONR6O1SClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

Doxepin hydrochloride

Product Details

NDC Product Code

27241-169

Application Number

ANDA212624

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

November 24, 2021

Ingredients

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

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

Doxepin hydrochloride

Product Details

NDC Product Code

27241-168

Application Number

ANDA212624

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

November 24, 2021

Ingredients

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

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

Doxepin hydrochloride

Product Details

NDC Product Code

27241-167

Application Number

ANDA212624

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

November 24, 2021

Ingredients

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

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

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