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BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: TEVA PHARMS USA INC · Approved 2026-04-23
Drug application
- FDA Application #
ANDA212212- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE
- Generic name
- Budesonide
- Active ingredients
- BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE
- Dosage form
- AEROSOL, METERED
- Route
- INHALATION
- Marketing status
- Prescription
- Sponsor
- TEVA PHARMS USA INC
- First approval
- 2026-04-23
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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