Application 020576
- Type
- NDA
- Sponsor
- ORPHAN EUROPE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CYSTADANE | BETAINE | FOR SOLUTION;ORAL | 1GM/SCOOPFUL | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 52276-400 | Cystadane | betaine | Recordati Rare Diseases | NDA | Current |
| 52276-400 | Cystadane | betaine | Orphan Europe SARL | NDA | Current |
| 52276-400 | Cystadane | betaine | Recordati Rare Diseases | NDA | Current |
| 64811-400 | Cystadane | BETAINE | Ropack Inc. | NDA | Current |
| 66621-4000 | Cystadane | betaine | Rare Disease Therapeutics, Inc. | NDA | Current |