# BUDESONIDE
> **ANDA078404** · Abbreviated New Drug Application (Generic) · Sponsor: IMPAX LABS INC · Approved 2012-07-31
## Drug
- **FDA Application Number:** ANDA078404
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** BUDESONIDE
- **Generic name:** BUDESONIDE
- **Active ingredients:** BUDESONIDE
- **Dosage form:** SUSPENSION
- **Route:** INHALATION
- **Marketing status:** Prescription
- **Sponsor:** IMPAX LABS INC
- **Manufacturer:** Amneal Pharmaceuticals of New York LLC
- **First approval:** 2012-07-31
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=078404)
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