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FDA NDA · NDA022549

ADASUVE

loxapine

Sponsor: NOVA PNEUMA

APPLICATION
NDA022549
TYPE
NDA
ORIGINAL APPROVAL
2012-12-21
LATEST ACTION
2022-01-27
ROUTE
RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

ADASUVE · ReferencePrescription
LOXAPINE 10MG · POWDER · INHALATION

Approval history

2022-01-27Labeling · Supplement 10 · standard — Letter ↗AP
2021-10-27Labeling · Supplement 9 · standard — Letter ↗AP
2017-02-23Labeling · Supplement 6 · 901 required — Label ↗AP
2016-09-28Labeling · Supplement 5 · standard — Letter ↗AP
2013-12-09REMS · Supplement 2 — Letter ↗AP
2012-12-21Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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