Albuterol Dry Powder Inhaler

Brand(s)
ProAir
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Teva Respiratory, Llc (2015-04-30)
Oldest Current Product
2015-04-27
License(s)
NDA
RxNORM
DRY POWDER INHALER\ALBUTEROL
FDAOB
INHALATION\POWDER, METERED\ALBUTEROL SULFATE\rdfq
SPL Active
RESPIRATORY (INHALATION)\POWDER, METERED\ALBUTEROL SULFATE
SPL Moiety
RESPIRATORY (INHALATION)\POWDER, METERED\ALBUTEROL

product(s) by strength(s)

200 actuat albuterol 0.09 mg/actuat dry powder inhaler

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1593100580ProAirNDATeva Respiratory, Llc2015-04-27ALBUTEROL SULFATERESPIRATORY (INHALATION)POWDER, METEREDNDA2056369324e2eb-26fd-4f14-9f10-e5aa467306f4

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA205636PROAIR RESPICLICKTEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC2015-03-31p6748947, SUBSTANCE
p6871646, SUBSTANCE
p6701917, SUBSTANCE
p6446627, SUBSTANCE
p7540282, SUBSTANCE
p6718972, SUBSTANCE
p8651103, SUBSTANCE
p8006690, SUBSTANCE
NEW PRODUCT [2018-03-12]NDA205636_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1NDA205636_001RXALBUTEROL SULFATE (EQ 0.090MG BASE/INH)POWDER, METEREDTrue2015-03-31PROAIR RESPICLICK

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p6446627 (view patent)2017-12-18NDA205636, NDA020911, NDA021457Beclomethasone Metered Dose Inhaler
Albuterol Metered Dose Inhaler
2p6701917 (view patent)2021-06-23NDA205636
3p6718972 (view patent)2021-06-23NDA205636
4p6748947 (view patent)2021-06-23NDA205636
5p6871646 (view patent)2021-06-23NDA205636
6p7540282 (view patent)2023-05-06NDA205636
7p8006690 (view patent)2021-06-23NDA205636
8p8651103 (view patent)2028-03-26NDA205636

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
19324e2eb-26fd-4f14-9f10-e5aa467306f4 (view SPL)These highlights do not include all the information needed to use PROAIR RESPICLICK safely and effectively. See full prescribing information for PROAIR RESPICLICK. PROAIR RESPICLICK (albuterol sulfate) inhalation powder, for oralinhalation useInitial U.S. Approval: 1981prescriptionHuman PrescriptionTeva Respiratory, Llc2015-04-302593100580

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