Mometasone Metered Dose Inhaler

Brand(s)
Asmanex
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Merck Sharp & Dohme Corp. (2015-08-03)
Oldest Current Product
2014-04-25
License(s)
NDA
RxNORM
METERED DOSE INHALER\MOMETASONE
FDAOB
INHALATION\AEROSOL, METERED\MOMETASONE FUROATE\rdfq
SPL Active
RESPIRATORY (INHALATION)\AEROSOL\MOMETASONE FUROATE
SPL Moiety
RESPIRATORY (INHALATION)\AEROSOL\MOMETASONE

product(s) by strength(s)

120 actuat mometasone furoate 0.1 mg/actuat metered dose inhaler

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000854333AsmanexNDAMerck Sharp & Dohme Corp.2014-04-25MOMETASONE FUROATERESPIRATORY (INHALATION)AEROSOLNDA2056411f608abd-d414-41e9-89bd-32dd2ef33cb8

120 actuat mometasone furoate 0.2 mg/actuat metered dose inhaler

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000854334AsmanexNDAMerck Sharp & Dohme Corp.2014-04-25MOMETASONE FUROATERESPIRATORY (INHALATION)AEROSOLNDA2056411f608abd-d414-41e9-89bd-32dd2ef33cb8

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA205641ASMANEX HFAMERCK SHARP AND DOHME CORP2014-04-25p6068832, TREATMENT OF ASTHMA, SUBSTANCENDA205641_001, NDA205641_002

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1NDA205641_001RXMOMETASONE FUROATE (0.10MG/INH)AEROSOL, METEREDFalse2014-04-25ASMANEX HFA
2NDA205641_002RXMOMETASONE FUROATE (0.20MG/INH)AEROSOL, METEREDTrue2014-04-25ASMANEX HFA

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p6068832 (view patent)2017-08-27NDA205641, NDA022518formoterol / Mometasone Metered Dose Inhaler

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
11f608abd-d414-41e9-89bd-32dd2ef33cb8 (view SPL)These highlights do not include all the information needed to use ASMANEX HFA safely and effectively. See full prescribing information for ASMANEX HFA. ASMANEX HFA 100 mcg (mometasone furoate) Inhalation Aerosol ASMANEX HFA 200 mcg (mometasone furoate) Inhalation Aerosol FOR ORAL INHALATION Initial U.S. Approval: 1987prescriptionHuman PrescriptionMerck Sharp & Dohme Corp.2015-08-034000854333, 000854334

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII