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PULMICORT FLEXHALER

NDA · New Drug Application · Sponsor: CHEPLAPHARM · Approved 2006-07-12

Drug application

FDA Application #
NDA021949
Application type
New Drug Application
Brand name
PULMICORT FLEXHALER
Generic name
BUDESONIDE
Active ingredients
BUDESONIDE
Dosage form
POWDER, METERED
Route
INHALATION
Marketing status
Prescription
Sponsor
CHEPLAPHARM
Manufacturer
H2-Pharma LLC
First approval
2006-07-12

Source

Authoritative
Drugs@FDA application overview
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