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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

NORTHSTAR RX LLC

DUNS: 830546433

Effective Date

October 21, 2020

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Doxepin(25 mg in 1 1)

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

16714-133

Application Number

ANDA213063

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

October 21, 2020

Ingredients

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

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

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

DOXEPIN HYDROCHLORIDE

Product Details

NDC Product Code

16714-135

Application Number

ANDA213063

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

October 21, 2020

Ingredients

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

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

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

DOXEPIN HYDROCHLORIDE

Product Details

NDC Product Code

16714-136

Application Number

ANDA213063

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

October 21, 2020

Ingredients

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

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

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

DOXEPIN HYDROCHLORIDE

Product Details

NDC Product Code

16714-134

Application Number

ANDA213063

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

October 21, 2020

Ingredients

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

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: 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

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

DOXEPIN HYDROCHLORIDE

Product Details

NDC Product Code

16714-132

Application Number

ANDA213063

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

October 21, 2020

Ingredients

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

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

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

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