EPURIS DIN 02396998
Health Canada record
| Active ingredient(s) | ISOTRETINOIN 20 MG |
|---|---|
| Dosage form | Capsule |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | D10BA01 ISOTRETINOIN |
| Original market date | 07-May-2013 |
| Current status date | 07-May-2013 |
| Source | Health Canada DPD |
Establishment licence of the holder
Cipher Pharmaceuticals Inc. — licence 102032, currently licensed, last inspection rating C (2023-02-07).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing ISOTRETINOIN
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02539055 | ABSORICA LD | SUN PHARMACEUTICAL INDUSTRIES LIMITED | Capsule | ISOTRETINOIN 16 MG | Marketed |
| 02539047 | ABSORICA LD | SUN PHARMACEUTICAL INDUSTRIES LIMITED | Capsule | ISOTRETINOIN 8 MG | Marketed |
| 02539071 | ABSORICA LD | SUN PHARMACEUTICAL INDUSTRIES LIMITED | Capsule | ISOTRETINOIN 32 MG | Marketed |
| 02539063 | ABSORICA LD | SUN PHARMACEUTICAL INDUSTRIES LIMITED | Capsule | ISOTRETINOIN 24 MG | Marketed |
| 00582344 | ACCUTANE | CHEPLAPHARM SCHWEIZ GMBH | Capsule | ISOTRETINOIN 10 MG | Marketed |
| 00582352 | ACCUTANE | CHEPLAPHARM SCHWEIZ GMBH | Capsule | ISOTRETINOIN 40 MG | Marketed |
| 02257963 | CLARUS | MYLAN PHARMACEUTICALS ULC | Capsule | ISOTRETINOIN 40 MG | Marketed |
| 02257955 | CLARUS | MYLAN PHARMACEUTICALS ULC | Capsule | ISOTRETINOIN 10 MG | Marketed |
| 02397005 | EPURIS | CIPHER PHARMACEUTICALS INC | Capsule | ISOTRETINOIN 30 MG | Marketed |
| 02397013 | EPURIS | CIPHER PHARMACEUTICALS INC | Capsule | ISOTRETINOIN 40 MG | Marketed |
| 02396971 | EPURIS | CIPHER PHARMACEUTICALS INC | Capsule | ISOTRETINOIN 10 MG | Marketed |
| 00784338 | ISOTREX GEL 0.05% | STIEFEL CANADA ULC | Gel | ISOTRETINOIN 0.05 % | Cancelled Post Market |
| 02309173 | RAN-ISOTRETINOIN | RANBAXY PHARMACEUTICALS CANADA INC. | Capsule | ISOTRETINOIN 10 MG | Cancelled Pre Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 13857 | 2012-11-19 | New Drug Submission (NDS) |
International API supply for ISOTRETINOIN
7 valid EDQM Certificates of Suitability from 7 holders. 10 active FDA Drug Master Files.
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