# LACTULOSE
> **ANDA090503** · Abbreviated New Drug Application (Generic) · Sponsor: FRESENIUS KABI · Approved 2012-01-25
## Drug
- **FDA Application Number:** ANDA090503
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** LACTULOSE
- **Generic name:** LACTULOSE
- **Active ingredients:** LACTULOSE
- **Dosage form:** SOLUTION
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** FRESENIUS KABI
- **Manufacturer:** Actavis Pharma, Inc.
- **First approval:** 2012-01-25
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=090503)
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