Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Lake Erie Medical DBA Quality Care Products LLC
Lake Erie Medical DBA Quality Care Products LLC
831276758
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fentanyl
Product Details
NDC Product Code
35356-635Application Number
ANDA076258Marketing Category
ANDA (C73584)Route of Administration
TRANSDERMALEffective Date
October 22, 2019DIMETHICONEInactive
Code: 92RU3N3Y1OClass: IACT
FentanylActive
Code: UF599785JZClass: ACTIBQuantity: 100 ug in 1 h
TRIMETHYLSILYL TREATED DIMETHICONOL/TRIMETHYLSILOXYSILICATE CROSSPOLYMER (40/60 W/W)Inactive
Code: 9N5G1G3D3HClass: IACT
Fentanyl
Product Details
NDC Product Code
35356-062Application Number
ANDA076258Marketing Category
ANDA (C73584)Route of Administration
TRANSDERMALEffective Date
October 22, 2019DIMETHICONEInactive
Code: 92RU3N3Y1OClass: IACT
FentanylActive
Code: UF599785JZClass: ACTIBQuantity: 12 ug in 1 h
TRIMETHYLSILYL TREATED DIMETHICONOL/TRIMETHYLSILOXYSILICATE CROSSPOLYMER (40/60 W/W)Inactive
Code: 9N5G1G3D3HClass: IACT