NDC 78206-125

Dulera

Mometasone Furoate And Formoterol Fumarate Dihydrate

Dulera is a Respiratory (inhalation) Aerosol in the Human Prescription Drug category. It is labeled and distributed by Organon Llc. The primary component is Mometasone Furoate; Formoterol Fumarate.

Product ID78206-125_810b1440-7c6d-4ac8-aa22-bb8b606e48b4
NDC78206-125
Product TypeHuman Prescription Drug
Proprietary NameDulera
Generic NameMometasone Furoate And Formoterol Fumarate Dihydrate
Dosage FormAerosol
Route of AdministrationRESPIRATORY (INHALATION)
Marketing Start Date2021-06-01
Marketing CategoryNDA /
Application NumberNDA022518
Labeler NameOrganon LLC
Substance NameMOMETASONE FUROATE; FORMOTEROL FUMARATE
Active Ingredient Strength50 ug/1; ug/1
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 78206-125-01

1 CANISTER in 1 CARTON (78206-125-01) > 120 AEROSOL in 1 CANISTER
Marketing Start Date2021-06-01
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Dulera" or generic name "Mometasone Furoate And Formoterol Fumarate Dihydrate"

NDCBrand NameGeneric Name
0085-2223Duleramometasone furoate and formoterol fumarate dihydrate
0085-4610Duleramometasone furoate and formoterol fumarate dihydrate
0085-7206Duleramometasone furoate and formoterol fumarate dihydrate
50090-1916Duleramometasone furoate and formoterol fumarate dihydrate
78206-125Duleramometasone furoate and formoterol fumarate dihydrate
78206-126Duleramometasone furoate and formoterol fumarate dihydrate
78206-127Duleramometasone furoate and formoterol fumarate dihydrate

Trademark Results [Dulera]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DULERA
DULERA
77651927 not registered Dead/Abandoned
Schering Corporation
2009-01-19
DULERA
DULERA
77651926 not registered Dead/Abandoned
Schering Corporation
2009-01-19
DULERA
DULERA
77194640 not registered Dead/Abandoned
MSP SINGAPORE COMPANY, LLC
2007-05-31
DULERA
DULERA
77194631 not registered Dead/Abandoned
MSP SINGAPORE COMPANY, LLC
2007-05-31
DULERA
DULERA
77095855 3419361 Live/Registered
MERCK SHARP & DOHME CORP.
2007-01-31

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