formoterol Inhalant Solution

Brand(s)
Perforomist
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Mylan Specialty L.P. (2013-03-22)
Oldest Current Product
2007-10-01
License(s)
NDA
RxNORM
INHALANT SOLUTION\FORMOTEROL
FDAOB
INHALATION\SOLUTION\FORMOTEROL FUMARATE\rdfq
SPL Active
RESPIRATORY (INHALATION)\SOLUTION\FORMOTEROL FUMARATE
SPL Moiety
RESPIRATORY (INHALATION)\SOLUTION\FORMOTEROL

product(s) by strength(s)

formoterol fumarate 0.01 mg/ml inhalant solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1495020605PerforomistNDAMylan Specialty L.P.2007-10-01FORMOTEROL FUMARATERESPIRATORY (INHALATION)SOLUTIONNDA022007fb2fe258-fe2e-47f6-8adf-ca75bf6f90af

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA022007PERFOROMISTMYLAN SPECIALTY LP2007-05-11p6667344, SUBSTANCE
p7348362, SUBSTANCE
p6814953, MAINTENANCE TREATMENT OF BRONCHOCONSTRICTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), SUBSTANCE
p8623922, SUBSTANCE
p7462645, MAINTENANCE TREATMENT OF BRONCHOCONSTRICTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), SUBSTANCE
NDA022007_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1NDA022007_001RXFORMOTEROL FUMARATE (0.02MG/2ML)SOLUTIONTrue2007-05-11PERFOROMIST

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p6667344 (view patent)2021-06-22NDA022007, NDA021912arformoterol Inhalant Solution
2p6814953 (view patent)2021-06-22NDA022007, NDA021912arformoterol Inhalant Solution
3p7348362 (view patent)2021-06-22NDA022007, NDA021912arformoterol Inhalant Solution
4p7462645 (view patent)2021-06-22NDA022007, NDA021912arformoterol Inhalant Solution
5p8623922 (view patent)2021-06-22NDA022007

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1fb2fe258-fe2e-47f6-8adf-ca75bf6f90af (view SPL)These highlights do not include all the information needed to use PERFOROMIST Inhalation Solution safely and effectively. See full prescribing information for PERFOROMIST Inhalation Solution.PERFOROMIST (formoterol fumarate) Inhalation Solution Initial U.S. Approval: 2001prescriptionHuman PrescriptionMylan Specialty L.P.2013-03-2212495020605

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