Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 205641

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ASMANEX HFA (MOMETASONE FUROATE)
0.05MG/INH
Marketing Status: Prescription

Active Ingredient: MOMETASONE FUROATE
Proprietary Name: ASMANEX HFA
Dosage Form; Route of Administration: AEROSOL, METERED; INHALATION
Strength: 0.05MG/INH
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N205641
Product Number: 003
Approval Date: Aug 12, 2019
Applicant Holder Full Name: ORGANON LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

ASMANEX HFA (MOMETASONE FUROATE)
0.10MG/INH
Marketing Status: Prescription

Active Ingredient: MOMETASONE FUROATE
Proprietary Name: ASMANEX HFA
Dosage Form; Route of Administration: AEROSOL, METERED; INHALATION
Strength: 0.10MG/INH
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N205641
Product Number: 001
Approval Date: Apr 25, 2014
Applicant Holder Full Name: ORGANON LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

ASMANEX HFA (MOMETASONE FUROATE)
0.20MG/INH
Marketing Status: Prescription

Active Ingredient: MOMETASONE FUROATE
Proprietary Name: ASMANEX HFA
Dosage Form; Route of Administration: AEROSOL, METERED; INHALATION
Strength: 0.20MG/INH
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N205641
Product Number: 002
Approval Date: Apr 25, 2014
Applicant Holder Full Name: ORGANON LLC
Marketing Status:  Prescription
Patent and Exclusivity Information