Dulera (Page 9 of 9)

mometasone furoate and formoterol fumarate dihydrate

Label ImageLabel Image
DULERA mometasone furoate and formoterol fumarate dihydrate aerosol
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-1916(NDC:0085-4610)
Route of Administration RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MOMETASONE FUROATE (MOMETASONE) MOMETASONE FUROATE 200 ug
FORMOTEROL FUMARATE (FORMOTEROL) FORMOTEROL FUMARATE 5 ug
Inactive Ingredients
Ingredient Name Strength
alcohol
oleic acid
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-1916-0 1 CANISTER in 1 CARTON contains a CANISTER
1 60 AEROSOL in 1 CANISTER This package is contained within the CARTON (50090-1916-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022518 06/22/2010
Labeler — A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions 830016429 RELABEL (50090-1916)

Revised: 12/2017 A-S Medication Solutions

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