← FDA Drug Approvals (Drugs@FDA)
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
- Machine
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