MedPath
FDA Approval

BREYNA

September 24, 2020

HUMAN PRESCRIPTION DRUG LABEL

Budesonide(80 ug in 1 1)
Formoterol(4.5 ug in 1 1)

Products (2)

BREYNA

0378-7502

ANDA211699

ANDA (C73584)

RESPIRATORY (INHALATION)

September 24, 2020

Code: Q3OKS62Q6XClass: ACTIBQuantity: 80 ug in 1 1
Code: W34SHF8J2KClass: ACTIBQuantity: 4.5 ug in 1 1
polyethylene glycol 1000Inactive
Code: U076Q6Q621Class: IACT
apafluraneInactive
Code: R40P36GDK6Class: IACT
povidone k25Inactive
Code: K0KQV10C35Class: IACT

BREYNA

0378-7503

ANDA211699

ANDA (C73584)

RESPIRATORY (INHALATION)

September 24, 2020

Code: W34SHF8J2KClass: ACTIBQuantity: 4.5 ug in 1 1
povidone k25Inactive
Code: K0KQV10C35Class: IACT
Code: Q3OKS62Q6XClass: ACTIBQuantity: 160 ug in 1 1
apafluraneInactive
Code: R40P36GDK6Class: IACT
polyethylene glycol 1000Inactive
Code: U076Q6Q621Class: IACT
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