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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
Effective Date
August 27, 2021
Labeling Type
Human Prescription Drug Label
Doxepin(150 mg in 1 1)

Products1

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
42799-935
Application Number
ANDA213796
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
May 26, 2022
DoxepinActive
Code: 3U9A0FE9N5Class: ACTIMQuantity: 150 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
SHELLACInactive
Code: MB5IUD6JUAClass: IACT
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
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