NDC Code(s) : 0115-1473-52, 0115-1473-45, 0115-1473-58
Packager : Impax Generics

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Fluticasone PropionateFluticasone Propionate CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0115-1473
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUTICASONE PROPIONATE(UNII: O2GMZ0LF5W)
(FLUTICASONE - UNII:CUT2W21N7U) 		FLUTICASONE PROPIONATE0.5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
MINERAL OIL(UNII: T5L8T28FGP)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
ISOPROPYL MYRISTATE(UNII: 0RE8K4LNJS)
SODIUM PHOSPHATE, DIBASIC(UNII: GR686LBA74)
CETETH-20(UNII: I835H2IHHX)
IMIDUREA(UNII: M629807ATL)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0115-1473-521 in 1 CARTON
115 g in 1 TUBE Type 0: Not a Combination Product
2NDC:0115-1473-451 in 1 CARTON
230 g in 1 TUBE Type 0: Not a Combination Product
3NDC:0115-1473-581 in 1 CARTON
360 g in 1 TUBE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076633 05/14/2004

PRINCIPAL DISPLAY PANEL

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