Proventil HFA (Page 4 of 4)

PRINCIPAL DISPLAY PANEL

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PROVENTIL HFA albuterol sulfate aerosol, metered
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-6051(NDC:0085-1132)
Route of Administration RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALBUTEROL SULFATE (ALBUTEROL) ALBUTEROL SULFATE 108 ug
Inactive Ingredients
Ingredient Name Strength
ALCOHOL
OLEIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-6051-0 200 AEROSOL, METERED (INHALATION) in 1 INHALER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020503 07/17/2009
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel

Revised: 10/2009 Physicians Total Care, Inc.

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