| 71469-231-01 |
71469-231 |
HUMAN PRESCRIPTION DRUG |
GLEOLAN |
AMINOLEVULINIC ACID HYDROCHLORIDE |
POWDER, FOR SOLUTION |
ORAL |
20180314 |
N/A |
NDA |
NDA208630 |
NX DEVELOPMENT CORP |
AMINOLEVULINIC ACID HYDROCHLORIDE |
1500 mg/1 |
1 VIAL, SINGLE-DOSE in 1 CARTON (71469-231-01) / 1 POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE |
| 59137-231-01 |
59137-231 |
HUMAN PRESCRIPTION DRUG |
GLEOLAN |
AMINOLEVULINIC ACID HYDROCHLORIDE |
POWDER, FOR SOLUTION |
ORAL |
20220301 |
N/A |
NDA |
NDA208630 |
Medexus Pharma, Inc. |
AMINOLEVULINIC ACID HYDROCHLORIDE |
1500 mg/1 |
1 VIAL, SINGLE-DOSE in 1 CARTON (59137-231-01) / 1 POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE |