Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 211699

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BREYNA (BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE)
0.08MG/INH;0.0045MG/INH
Marketing Status: Prescription

Active Ingredient: BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE
Proprietary Name: BREYNA
Dosage Form; Route of Administration: AEROSOL, METERED; INHALATION
Strength: 0.08MG/INH;0.0045MG/INH
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A211699
Product Number: 001
Approval Date: Mar 15, 2022
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

BREYNA (BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE)
0.16MG/INH;0.0045MG/INH
Marketing Status: Prescription

Active Ingredient: BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE
Proprietary Name: BREYNA
Dosage Form; Route of Administration: AEROSOL, METERED; INHALATION
Strength: 0.16MG/INH;0.0045MG/INH
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A211699
Product Number: 002
Approval Date: Mar 15, 2022
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information