PROTOPIC DIN 02244148
Health Canada record
| Active ingredient(s) | TACROLIMUS 0.1 % |
|---|---|
| Dosage form | Ointment |
| Route | Topical |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | D11AH01 TACROLIMUS |
| Original market date | 06-Sep-2001 |
| Current status date | 25-May-2017 |
| Source | Health Canada DPD |
Establishment licence of the holder
LEO Pharma Inc — licence 100195, currently licensed, last inspection rating C (2026-05-27).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing TACROLIMUS
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02456095 | ACH-TACROLIMUS | ACCORD HEALTHCARE INC | Capsule (Immediate-Release) | TACROLIMUS 1 MG | Marketed |
| 02454068 | ACH-TACROLIMUS | ACCORD HEALTHCARE INC | Capsule (Immediate-Release) | TACROLIMUS 0.5 MG | Marketed |
| 02456109 | ACH-TACROLIMUS | ACCORD HEALTHCARE INC | Capsule (Immediate-Release) | TACROLIMUS 5 MG | Marketed |
| 02296489 | ADVAGRAF | ASTELLAS PHARMA CANADA INC | Capsule (Extended-Release) | TACROLIMUS 5 MG | Marketed |
| 02331667 | ADVAGRAF | ASTELLAS PHARMA CANADA INC | Capsule (Extended-Release) | TACROLIMUS 3 MG | Marketed |
| 02296462 | ADVAGRAF | ASTELLAS PHARMA CANADA INC | Capsule (Extended-Release) | TACROLIMUS 0.5 MG | Marketed |
| 02296470 | ADVAGRAF | ASTELLAS PHARMA CANADA INC | Capsule (Extended-Release) | TACROLIMUS 1 MG | Marketed |
| 02459213 | APO-TACROLIMUS | APOTEX INC | Capsule (Immediate-Release) | TACROLIMUS 0.5 MG | Approved |
| 02474506 | APO-TACROLIMUS CAPSULES | APOTEX INC | Capsule (Immediate-Release) | TACROLIMUS 1 MG | Approved |
| 02474514 | APO-TACROLIMUS CAPSULES | APOTEX INC | Capsule (Immediate-Release) | TACROLIMUS 5 MG | Approved |
| 02485893 | ENVARSUS PA | KNIGHT THERAPEUTICS INC. | Tablet (Extended-Release) | TACROLIMUS 4 MG | Marketed |
| 02485885 | ENVARSUS PA | KNIGHT THERAPEUTICS INC. | Tablet (Extended-Release) | TACROLIMUS 1 MG | Marketed |
| 02485877 | ENVARSUS PA | KNIGHT THERAPEUTICS INC. | Tablet (Extended-Release) | TACROLIMUS 0.75 MG | Marketed |
| 02569264 | JAMP TACROLIMUS OINTMENT | JAMP PHARMA CORPORATION | Ointment | TACROLIMUS 0.1 % | Approved |
| 02531380 | LEO PHARMA - TACROLIMUS | LEO PHARMA GEN, A DIVISION OF LEO PHARMA INC. | Ointment | TACROLIMUS 0.1 % | Approved |
| 02531399 | LEO PHARMA - TACROLIMUS | LEO PHARMA GEN, A DIVISION OF LEO PHARMA INC. | Ointment | TACROLIMUS 0.03 % | Approved |
| 02175983 | PROGRAF | ASTELLAS PHARMA CANADA INC | Capsule | TACROLIMUS 5 MG | Marketed |
| 02175991 | PROGRAF | ASTELLAS PHARMA CANADA INC | Capsule | TACROLIMUS 1 MG | Marketed |
| 02176009 | PROGRAF | ASTELLAS PHARMA CANADA INC | Solution | TACROLIMUS 5 MG | Marketed |
| 02243144 | PROGRAF | ASTELLAS PHARMA CANADA INC | Capsule | TACROLIMUS 0.5 MG | Marketed |
| 02244149 | PROTOPIC | LEO PHARMA INC | Ointment | TACROLIMUS 0.03 % | Marketed |
| 02528606 | SANDOZ TACROLIMUS XR | SANDOZ CANADA INCORPORATED | Capsule (Extended-Release) | TACROLIMUS 1 MG | Marketed |
| 02528614 | SANDOZ TACROLIMUS XR | SANDOZ CANADA INCORPORATED | Capsule (Extended-Release) | TACROLIMUS 2 MG | Approved |
| 02528622 | SANDOZ TACROLIMUS XR | SANDOZ CANADA INCORPORATED | Capsule (Extended-Release) | TACROLIMUS 3 MG | Marketed |
| 02528592 | SANDOZ TACROLIMUS XR | SANDOZ CANADA INCORPORATED | Capsule (Extended-Release) | TACROLIMUS 0.5 MG | Marketed |
| 02528630 | SANDOZ TACROLIMUS XR | SANDOZ CANADA INCORPORATED | Capsule (Extended-Release) | TACROLIMUS 5 MG | Marketed |
| 02460238 | JAMP-TACROLIMUS | JAMP PHARMA CORPORATION | Capsule (Immediate-Release) | TACROLIMUS 0.5 MG | Cancelled Pre Market |
| 02453428 | TARO-TACROLIMUS | SUN PHARMA CANADA INC | Capsule (Immediate-Release) | TACROLIMUS 5 MG | Cancelled Pre Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 18198 | 2016-06-22 | New Drug Submission (NDS) | TRANSFER OF DRUG IDENTIFICATION NUMBER |
| 6431 | 2005-04-12 | New Drug Submission (NDS) | MANUFACTURER NAME CHANGE |
| 2636 | 2001-06-25 | New Drug Submission (NDS) |
International API supply for TACROLIMUS
26 active FDA Drug Master Files.
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