DILANTIN DIN 00022772
Health Canada record
| Active ingredient(s) | PHENYTOIN SODIUM 30 MG |
|---|---|
| Dosage form | Capsule |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | N03AB02 PHENYTOIN |
| Original market date | 31-Dec-1951 |
| Current status date | 07-Jun-2023 |
| Source | Health Canada DPD |
Establishment licence of the holder
BGP Pharma ULC — licence 102234, currently licensed, last inspection rating C (2026-02-24).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing PHENYTOIN SODIUM
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 00022780 | DILANTIN | BGP PHARMA ULC | Capsule | PHENYTOIN SODIUM 100 MG | Marketed |
| 02460912 | PHENYTOIN SODIUM | AA PHARMA INC | Capsule | PHENYTOIN SODIUM 100 MG | Marketed |
| 02431378 | PHENYTOIN SODIUM INJECTION USP | HIKMA CANADA LIMITED | Solution | PHENYTOIN SODIUM 50 MG | Marketed |
| 00780626 | PHENYTOIN SODIUM INJECTION USP | SANDOZ CANADA INCORPORATED | Liquid | PHENYTOIN SODIUM 50 MG | Marketed |
| 00245453 | DILANTIN INJ 50MG/ML | PARKE-DAVIS DIVISION, WARNER-LAMBERT CANADA INC. | Liquid | PHENYTOIN SODIUM 250 MG | Cancelled Post Market |
| 00275131 | DILANTIN W PHENOBARBITAL 15MG | PARKE-DAVIS DIVISION, WARNER-LAMBERT CANADA INC. | Capsule | PHENYTOIN SODIUM 100 MG; PHENOBARBITAL 15 MG | Cancelled Post Market |
| 00439770 | DILANTIN W PHENOBARBITAL 30MG CAP | PARKE-DAVIS DIVISION, WARNER-LAMBERT CANADA INC. | Capsule | PHENYTOIN SODIUM 100 MG; PHENOBARBITAL 30 MG | Cancelled Post Market |
| 00037435 | NOVO-PHENYTOIN CAP 100MG | NOVOPHARM LIMITED | Capsule | PHENYTOIN SODIUM 100 MG | Cancelled Post Market |
| 00498335 | PHENYTOIN SODIUM INJECTION USP | JUNO PHARMA CANADA INC. | Solution | PHENYTOIN SODIUM 50 MG | Dormant |
| 00497304 | PHENYTOIN SOIDUM INJECTION USP | PFIZER CANADA ULC | Solution | PHENYTOIN SODIUM 50 MG | Cancelled Post Market |
| 02468255 | TARO-PHENYTOIN | TARO PHARMACEUTICALS INC | Capsule | PHENYTOIN SODIUM 100 MG | Cancelled Pre Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 30937 | 2023-06-07 | New Drug Submission (NDS) | Administrative: Change in Product Ownership |
| 23606 | 2020-05-13 | New Drug Submission (NDS) | CHANGE IN PRODUCT OWNERSHIP |
International API supply for PHENYTOIN SODIUM
1 valid EDQM Certificates of Suitability from 1 holders. 12 active FDA Drug Master Files.
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