aclidinium Dry Powder Inhaler

Brand(s)
Tudorza
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Forest Laboratories, Inc (2015-04-09)
Oldest Current Product
2012-07-23
License(s)
NDA
RxNORM
DRY POWDER INHALER\ACLIDINIUM
FDAOB
INHALATION\POWDER, METERED\ACLIDINIUM BROMIDE\rdfq
SPL Active
RESPIRATORY (INHALATION)\INHALANT\ACLIDINIUM BROMIDE
SPL Moiety
RESPIRATORY (INHALATION)\INHALANT\ACLIDINIUM BROMIDE

product(s) by strength(s)

aclidinium bromide 0.4 mg/actuat dry powder inhaler

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004560800TudorzaNDAForest Laboratories, Inc2012-07-23ACLIDINIUM BROMIDERESPIRATORY (INHALATION)INHALANTNDA2024500be80491-cb6c-488b-964c-18777d7f5ab9

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA202450TUDORZA PRESSAIRASTRAZENECA PHARMACEUTICALS LP2012-07-23p6750226, TREATMENT OF A RESPIRATORY DISEASE, SUBSTANCE
p9056100, TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) OR CHRONIC BRONCHITIS, SUBSTANCE
p8051851, SUBSTANCE
p6681768, SUBSTANCE
p7078412, TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) OR CHRONIC BRONCHITIS, SUBSTANCE
p6071498, SUBSTANCE
p5840279, SUBSTANCE
NEW CHEMICAL ENTITY [2017-07-23]NDA202450_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1NDA202450_001RXACLIDINIUM BROMIDE (0.4MG/INH)POWDER, METEREDTrue2012-07-23TUDORZA PRESSAIR

patent(s)

#idexpiration dateapplication(s)
1p5840279 (view patent)2016-06-21NDA202450
2p6071498 (view patent)2016-06-21NDA202450
3p6681768 (view patent)2022-08-07NDA202450
4p6750226 (view patent)2020-09-05NDA202450
5p7078412 (view patent)2020-07-16NDA202450
6p8051851 (view patent)2027-04-22NDA202450
7p9056100 (view patent)2020-07-07NDA202450

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10be80491-cb6c-488b-964c-18777d7f5ab9 (view SPL)These highlights do not include all the information needed to use TUDORZA PRESSAIR safely and effectively. See full prescribing information for TUDORZA PRESSAIR.TUDORZA PRESSAIR (aclidinium bromide inhalation powder)FOR ORAL INHALATION ONLYInitial U.S. Approval: 2012prescriptionHuman PrescriptionForest Laboratories, IncMANUFACTURE2015-04-096004560800
2acdd5932-375b-4966-8a06-3806ab74c36d (view SPL)These highlights do not include all the information needed to use TUDORZA PRESSAIR safely and effectively. See full prescribing information for TUDORZA PRESSAIR.TUDORZA PRESSAIR (aclidinium bromide inhalation powder)FOR ORAL INHALATION ONLYInitial U.S. Approval: 2012prescriptionHuman PrescriptionAstrazeneca Pharmaceuticals Lp2015-07-012003100800

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