Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022518

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DULERA (FORMOTEROL FUMARATE; MOMETASONE FUROATE)
0.005MG/INH;0.05MG/INH
Marketing Status: Prescription

Active Ingredient: FORMOTEROL FUMARATE; MOMETASONE FUROATE
Proprietary Name: DULERA
Dosage Form; Route of Administration: AEROSOL, METERED; INHALATION
Strength: 0.005MG/INH;0.05MG/INH
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022518
Product Number: 003
Approval Date: Aug 12, 2019
Applicant Holder Full Name: ORGANON LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

DULERA (FORMOTEROL FUMARATE; MOMETASONE FUROATE)
0.005MG/INH;0.1MG/INH
Marketing Status: Prescription

Active Ingredient: FORMOTEROL FUMARATE; MOMETASONE FUROATE
Proprietary Name: DULERA
Dosage Form; Route of Administration: AEROSOL, METERED; INHALATION
Strength: 0.005MG/INH;0.1MG/INH
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N022518
Product Number: 001
Approval Date: Jun 22, 2010
Applicant Holder Full Name: ORGANON LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

DULERA (FORMOTEROL FUMARATE; MOMETASONE FUROATE)
0.005MG/INH;0.2MG/INH
Marketing Status: Prescription

Active Ingredient: FORMOTEROL FUMARATE; MOMETASONE FUROATE
Proprietary Name: DULERA
Dosage Form; Route of Administration: AEROSOL, METERED; INHALATION
Strength: 0.005MG/INH;0.2MG/INH
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N022518
Product Number: 002
Approval Date: Jun 22, 2010
Applicant Holder Full Name: ORGANON LLC
Marketing Status:  Prescription
Patent and Exclusivity Information