KUVAN DIN 02482207
Status: Marketed
Holder: BIOMARIN INTERNATIONAL LIMITED
Molecule: SAPROPTERIN DIHYDROCHLORIDE
Available to quote
Health Canada record
| Active ingredient(s) | SAPROPTERIN DIHYDROCHLORIDE 100 MG |
|---|---|
| Dosage form | Powder |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | A16AX07 SAPROPTERIN |
| Original market date | 05-Dec-2019 |
| Current status date | 05-Dec-2019 |
| Source | Health Canada DPD |
Establishment licence of the holder
BioMarin International Limited — licence , not currently licensed, last inspection rating C (2024-02-16).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing SAPROPTERIN DIHYDROCHLORIDE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02547481 | ALOG-SAPROPTERIN | ANALOG PHARMA CANADA INC. | Tablet | SAPROPTERIN DIHYDROCHLORIDE 100 MG | Approved |
| 02350580 | KUVAN | BIOMARIN INTERNATIONAL LIMITED | Tablet | SAPROPTERIN DIHYDROCHLORIDE 100 MG | Marketed |
| 02534533 | REDDY-SAPROPTERIN | DR REDDY'S LABORATORIES LTD | Powder For Solution | SAPROPTERIN DIHYDROCHLORIDE 100 MG | Marketed |
| 02535610 | REDDY-SAPROPTERIN | DR REDDY'S LABORATORIES LTD | Powder For Solution | SAPROPTERIN DIHYDROCHLORIDE 500 MG | Marketed |
| 02482215 | KUVAN | BIOMARIN INTERNATIONAL LIMITED | Powder | SAPROPTERIN DIHYDROCHLORIDE 500 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 21973 | 2019-03-14 | New Drug Submission (NDS) | MANUFACTURER NAME CHANGE |
| 21507 | 2018-11-08 | Supplement to a New Drug Submission (SNDS) | New Form: Powder |
International API supply for SAPROPTERIN DIHYDROCHLORIDE
8 active FDA Drug Master Files.
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