Dulera is a Respiratory (inhalation) Aerosol in the Human Prescription Drug category. It is labeled and distributed by Organon Llc. The primary component is Formoterol Fumarate; Mometasone Furoate.
Product ID | 78206-125_033d28d6-fd11-406a-ad78-09cd64dad41d |
NDC | 78206-125 |
Product Type | Human Prescription Drug |
Proprietary Name | Dulera |
Generic Name | Mometasone Furoate And Formoterol Fumarate Dihydrate |
Dosage Form | Aerosol |
Route of Administration | RESPIRATORY (INHALATION) |
Marketing Start Date | 2021-06-01 |
Marketing Category | NDA / |
Application Number | NDA022518 |
Labeler Name | Organon LLC |
Substance Name | FORMOTEROL FUMARATE; MOMETASONE FUROATE |
Active Ingredient Strength | 5 ug/1; ug/1 |
Pharm Classes | Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC] |
NDC Exclude Flag | N |
Listing Certified Through | 2023-12-31 |
Marketing Start Date | 2021-06-01 |
NDC Exclude Flag | N |
Sample Package? | N |
NDC | Brand Name | Generic Name |
---|---|---|
0085-2223 | Dulera | mometasone furoate and formoterol fumarate dihydrate |
0085-4610 | Dulera | mometasone furoate and formoterol fumarate dihydrate |
0085-7206 | Dulera | mometasone furoate and formoterol fumarate dihydrate |
50090-1916 | Dulera | mometasone furoate and formoterol fumarate dihydrate |
78206-125 | Dulera | mometasone furoate and formoterol fumarate dihydrate |
78206-126 | Dulera | mometasone furoate and formoterol fumarate dihydrate |
78206-127 | Dulera | mometasone furoate and formoterol fumarate dihydrate |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
DULERA 77651927 not registered Dead/Abandoned |
Schering Corporation 2009-01-19 |
DULERA 77651926 not registered Dead/Abandoned |
Schering Corporation 2009-01-19 |
DULERA 77194640 not registered Dead/Abandoned |
MSP SINGAPORE COMPANY, LLC 2007-05-31 |
DULERA 77194631 not registered Dead/Abandoned |
MSP SINGAPORE COMPANY, LLC 2007-05-31 |
DULERA 77095855 3419361 Live/Registered |
MERCK SHARP & DOHME CORP. 2007-01-31 |