Application 208630
- Type
- NDA
- Sponsor
- NXDC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | GLEOLAN | AMINOLEVULINIC ACID HYDROCHLORIDE | FOR SOLUTION;ORAL | 1.5GM/VIAL | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 59137-231 | GLEOLAN | AMINOLEVULINIC ACID HYDROCHLORIDE | Medexus Pharma, Inc. | NDA | Current |
| 71469-231 | GLEOLAN | AMINOLEVULINIC ACID HYDROCHLORIDE | NX DEVELOPMENT CORP | NDA | Current |
| 71469-231 | GLEOLAN | AMINOLEVULINIC ACID HYDROCHLORIDE | NX DEVELOPMENT CORP | NDA | Current |