# IBUPROFEN
> **ANDA078558** · Abbreviated New Drug Application (Generic) · Sponsor: AMNEAL PHARMS NY · Approved 2007-06-18
## Drug
- **FDA Application Number:** ANDA078558
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** IBUPROFEN
- **Generic name:** IBUPROFEN
- **Active ingredients:** IBUPROFEN
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** AMNEAL PHARMS NY
- **Manufacturer:** Amneal Pharmaceuticals of New York LLC
- **First approval:** 2007-06-18
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=078558)
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