NDC 0378-7502

BREYNA

Budesonide And Formoterol Fumarate

BREYNA is a Respiratory (inhalation) Aerosol, Metered in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Budesonide; Formoterol Fumarate.

Product ID0378-7502_dc529fc4-bddb-4673-8202-dc401f86166f
NDC0378-7502
Product TypeHuman Prescription Drug
Proprietary NameBREYNA
Generic NameBudesonide And Formoterol Fumarate
Dosage FormAerosol, Metered
Route of AdministrationRESPIRATORY (INHALATION)
Marketing Start Date2022-04-01
Marketing CategoryANDA /
Application NumberANDA211699
Labeler NameMylan Pharmaceuticals Inc.
Substance NameBUDESONIDE; FORMOTEROL FUMARATE
Active Ingredient Strength80 ug/1; ug/1
Pharm ClassesAdrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Drug Details

NDC Crossover Matching brand name "BREYNA" or generic name "Budesonide And Formoterol Fumarate"

NDCBrand NameGeneric Name
0378-7502BREYNABudesonide and Formoterol Fumarate
0378-7503BREYNABudesonide and Formoterol Fumarate

Trademark Results [BREYNA]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BREYNA
BREYNA
97936938 not registered Live/Pending
Mylan Pharmaceuticals Inc.
2023-05-15
BREYNA
BREYNA
97351431 not registered Live/Pending
Mylan Pharmaceuticals, Inc.
2022-04-07
BREYNA
BREYNA
88634036 not registered Live/Pending
Mylan Pharmaceuticals, Inc.
2019-09-27
BREYNA
BREYNA
87930172 not registered Live/Pending
Mylan Pharmaceuticals, Inc
2018-05-21
BREYNA
BREYNA
87241508 not registered Dead/Abandoned
Mylan Pharmaceuticals, Inc.
2016-11-18

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