Adasuve (Page 6 of 6)

PRINCIPAL DISPLAY PANEL

NDC XXXXX-XXX-XX

FOR ORAL INHALATION ONLY

adasuve
(loxapine) inhalation powder

10 mg

5 single dose units per carton

Rx ONLY

ADASUVE is contraindicated in patients with acute respiratory signs/symptoms (eg, wheezing) or who are taking medications to treat asthma or COPD.


adasuve-12
(click image for full-size original)

ADASUVE loxapine aerosol, powder
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51097-001
Route of Administration RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LOXAPINE (LOXAPINE) LOXAPINE 10 mg
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51097-001-02 5 INHALER in 1 CARTON contains a INHALER (51097-001-01)
1 NDC:51097-001-01 1 AEROSOL, POWDER in 1 INHALER This package is contained within the CARTON (51097-001-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022549 12/21/2012
Labeler — Alexza Pharmaceuticals, Inc. (018849948)
Establishment
Name Address ID/FEI Operations
Alexza Pharmaceuticals, Inc. 018849948 manufacture (51097-001)

Revised: 12/2012 Alexza Pharmaceuticals, Inc.

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