Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021067

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ASMANEX TWISTHALER (MOMETASONE FUROATE)
0.11MG/INH Marketing Status: Prescription

Active Ingredient: MOMETASONE FUROATE
Proprietary Name: ASMANEX TWISTHALER
Dosage Form; Route of Administration: POWDER; INHALATION
Strength: 0.11MG/INH
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021067
Product Number: 002
Approval Date: Feb 1, 2008
Applicant Holder Full Name: MERCK SHARP AND DOHME CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

ASMANEX TWISTHALER (MOMETASONE FUROATE)
0.22MG/INH Marketing Status: Prescription

Active Ingredient: MOMETASONE FUROATE
Proprietary Name: ASMANEX TWISTHALER
Dosage Form; Route of Administration: POWDER; INHALATION
Strength: 0.22MG/INH
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021067
Product Number: 001
Approval Date: Mar 30, 2005
Applicant Holder Full Name: MERCK SHARP AND DOHME CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

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