# CYSTADANE
> **NDA020576** · New Drug Application · Sponsor: RECORDATI RARE · Approved 1996-10-25
## Drug
- **FDA Application Number:** NDA020576
- **Application type:** New Drug Application
- **Brand name:** CYSTADANE
- **Generic name:** BETAINE
- **Active ingredients:** BETAINE
- **Dosage form:** FOR SOLUTION
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** RECORDATI RARE
- **Manufacturer:** Recordati Rare Diseases
- **First approval:** 1996-10-25
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020576)
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