Loxapine Dry Powder Inhaler

Brand(s)
Adasuve
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Teva Select Brands (2015-11-19)
Oldest Current Product
2014-01-22
License(s)
NDA
RxNORM
DRY POWDER INHALER\LOXAPINE
FDAOB
INHALATION\POWDER\LOXAPINE\rdfq
SPL Active
RESPIRATORY (INHALATION)\AEROSOL, POWDER\LOXAPINE
SPL Moiety
RESPIRATORY (INHALATION)\AEROSOL, POWDER\LOXAPINE

product(s) by strength(s)

1 actuat loxapine 10 mg/actuat dry powder inhaler

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1578440510AdasuveNDATeva Select Brands2014-01-22LOXAPINERESPIRATORY (INHALATION)AEROSOL, POWDERNDA022549b074f950-246a-41f0-aedf-32f38998a4b1

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA022549ADASUVETEVA PHARMACEUTICALS USA INC2012-12-21p8173107, SUBSTANCE
p7090830, SUBSTANCE
p6716416, SUBSTANCE
p7585493, SUBSTANCE
p7458374, SUBSTANCE
p8387612, SUBSTANCE
p7052679, SUBSTANCE
p8991387, SUBSTANCE
p8074644, SUBSTANCE
p8235037, SUBSTANCE
p8955512, SUBSTANCE
p7078020, ADASUVE IS A TYPICAL ANTIPSYCHOTIC INDICATED FOR THE ACUTE TREATMENT OF AGITATION ASSOCIATED WITH SCHIZOPHRENIA OR BIPOLAR I DISORDER IN ADULTS, SUBSTANCE
p7537009, SUBSTANCE
p7601337, SUBSTANCE
NEW DOSAGE FORM [2015-12-21]NDA022549_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1NDA022549_001RXLOXAPINE (10MG)POWDERTrue2012-12-21ADASUVE

patent(s)

#idexpiration dateapplication(s)
1p6716416 (view patent)2022-05-20NDA022549
2p7052679 (view patent)2021-10-26NDA022549
3p7078020 (view patent)2021-10-26NDA022549
4p7090830 (view patent)2021-10-26NDA022549
5p7458374 (view patent)2024-08-18NDA022549
6p7537009 (view patent)2024-10-28NDA022549
7p7585493 (view patent)2021-10-26NDA022549
8p7601337 (view patent)2021-10-26NDA022549
9p8074644 (view patent)2022-07-25NDA022549
10p8173107 (view patent)2021-10-26NDA022549
11p8235037 (view patent)2021-10-26NDA022549
12p8387612 (view patent)2026-10-23NDA022549
13p8955512 (view patent)2021-10-26NDA022549
14p8991387 (view patent)2024-05-21NDA022549

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1b074f950-246a-41f0-aedf-32f38998a4b1 (view SPL)These highlights do not include all the information needed to use ADASUVE safely and effectively. See full prescribing information for ADASUVE. ADASUVE (loxapine) inhalation powder, for oral inhalation use Initial U.S. Approval: 1975prescriptionHuman PrescriptionTeva Select Brands2015-11-193578440510

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