MedPath
FDA Approval

Doxepin Hydrochloride

August 17, 2023

HUMAN PRESCRIPTION DRUG LABEL

Doxepin(50 mg in 1 g)

Manufacturing Establishments (1)

Amneal Pharmaceuticals, LLC

Amneal Pharmaceuticals NY LLC

079389286

Products (1)

Doxepin Hydrochloride

69238-1733

ANDA212357

ANDA (C73584)

TOPICAL

August 17, 2023

DoxepinActive
Code: 3U9A0FE9N5Class: ACTIMQuantity: 50 mg in 1 g
SORBITOLInactive
Code: 506T60A25RClass: IACT
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJSClass: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCNClass: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4Class: IACT
POLYOXYL 100 STEARATEInactive
Code: YD01N1999RClass: IACT
PETROLATUMInactive
Code: 4T6H12BN9UClass: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
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