LEVULAN KERASTICK DIN 02243933
Status: Marketed
Holder: SUN PHARMACEUTICAL INDUSTRIES, INC.
Molecule: AMINOLEVULINIC ACID HYDROCHLORIDE
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Health Canada record
| Active ingredient(s) | AMINOLEVULINIC ACID HYDROCHLORIDE 20 % |
|---|---|
| Dosage form | Powder For Solution |
| Route | Topical |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | L01XD04 AMINOLEVULINIC ACID |
| Original market date | 03-Jun-2004 |
| Current status date | 22-Jul-2025 |
| Source | Health Canada DPD |
Establishment licence of the holder
Sun Pharmaceutical Industries Limited — licence , not currently licensed, last inspection rating C (2026-02-04).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing AMINOLEVULINIC ACID HYDROCHLORIDE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02504928 | GLEOLAN | MEDEXUS PHARMACEUTICALS INC. | Powder For Solution | AMINOLEVULINIC ACID HYDROCHLORIDE 1.5 G | Marketed |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 34703 | 2025-01-20 | New Drug Submission (NDS) | Administrative: Licensing Agreement between two manufacturers |
| 521 | 2004-04-05 | New Drug Submission (NDS) | MANUFACTURER NAME CHANGE |
| 886 | 2001-06-20 | New Drug Submission (NDS) |
International API supply for AMINOLEVULINIC ACID HYDROCHLORIDE
3 active FDA Drug Master Files.
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