ACT FLUCONAZOLE DIN 02281260
Health Canada record
| Active ingredient(s) | FLUCONAZOLE 50 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | J02AC01 FLUCONAZOLE |
| Original market date | 03-Dec-2007 |
| Current status date | 16-Apr-2020 |
| Source | Health Canada DPD |
Establishment licence of the holder
Teva Canada Limited — licence 101810, currently licensed, last inspection rating C (2025-03-04).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing FLUCONAZOLE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02281279 | ACT FLUCONAZOLE | TEVA CANADA LIMITED | Tablet | FLUCONAZOLE 100 MG | Marketed |
| 02237371 | APO-FLUCONAZOLE | APOTEX INC | Tablet | FLUCONAZOLE 100 MG | Marketed |
| 02237370 | APO-FLUCONAZOLE | APOTEX INC | Tablet | FLUCONAZOLE 50 MG | Marketed |
| 02237372 | APO-FLUCONAZOLE | APOTEX INC | Tablet | FLUCONAZOLE 200 MG | Approved |
| 02241895 | APO-FLUCONAZOLE-150 | APOTEX INC | Capsule | FLUCONAZOLE 150 MG | Marketed |
| 02311690 | CANESORAL | BAYER INC | Capsule | FLUCONAZOLE 150 MG | Marketed |
| 00891835 | DIFLUCAN | PFIZER CANADA ULC | Solution | FLUCONAZOLE 2 MG | Marketed |
| 02024152 | DIFLUCAN | PFIZER CANADA ULC | Powder For Solution | FLUCONAZOLE 50 MG | Marketed |
| 02141442 | DIFLUCAN ONE | PFIZER CANADA ULC | Capsule | FLUCONAZOLE 150 MG | Marketed |
| 02340038 | FLUCONAZOLE | PENDOPHARM DIVISION OF PHARMASCIENCE INC | Capsule | FLUCONAZOLE 150 MG | Approved |
| 02433095 | FLUCONAZOLE 150 | TARO PHARMACEUTICALS INC | Capsule | FLUCONAZOLE 150 MG | Approved |
| 02352133 | FLUCONAZOLE 150 | APOTEX INC | Capsule | FLUCONAZOLE 150 MG | Marketed |
| 02261472 | FLUCONAZOLE IN SODIUM CHLORIDE INJECTION USP | BAXTER CORPORATION | Solution | FLUCONAZOLE 2 MG | Marketed |
| 02388448 | FLUCONAZOLE INJECTION SDZ | SANDOZ CANADA INCORPORATED | Solution | FLUCONAZOLE 2 MG | Marketed |
| 02091216 | FLUCONAZOLE TABLETS | APOTEX INC | Tablet | FLUCONAZOLE 50 MG | Approved |
| 02091372 | FLUCONAZOLE TABLETS | APOTEX INC | Tablet | FLUCONAZOLE 100 MG | Approved |
| 02091380 | FLUCONAZOLE TABLETS | APOTEX INC | Tablet | FLUCONAZOLE 200 MG | Approved |
| 02428792 | MAR-FLUCONAZOLE-150 | MARCAN PHARMACEUTICALS INC | Capsule | FLUCONAZOLE 150 MG | Marketed |
| 02245293 | MYLAN-FLUCONAZOLE | MYLAN PHARMACEUTICALS ULC | Tablet | FLUCONAZOLE 100 MG | Marketed |
| 02245292 | MYLAN-FLUCONAZOLE | MYLAN PHARMACEUTICALS ULC | Tablet | FLUCONAZOLE 50 MG | Marketed |
| 02433702 | NRA-FLUCONAZOLE-150 | NORA PHARMA INC | Capsule | FLUCONAZOLE 150 MG | Marketed |
| 02245643 | PMS-FLUCONAZOLE | PHARMASCIENCE INC | Tablet | FLUCONAZOLE 50 MG | Marketed |
| 02245644 | PMS-FLUCONAZOLE | PHARMASCIENCE INC | Tablet | FLUCONAZOLE 100 MG | Marketed |
| 02310686 | PRO-FLUCONAZOLE | PRO DOC LIMITEE | Tablet | FLUCONAZOLE 100 MG | Marketed |
| 02255510 | RIVA-FLUCONAZOLE | LABORATOIRE RIVA INC. | Capsule | FLUCONAZOLE 150 MG | Marketed |
| 02249316 | TARO-FLUCONAZOLE | TARO PHARMACEUTICALS INC | Tablet | FLUCONAZOLE 200 MG | Approved |
| 02311739 | CANESORAL COMBI | BAYER INC | Cream; Capsule | FLUCONAZOLE 150 MG; CLOTRIMAZOLE 1 % | Cancelled Post Market |
| 02445131 | CLOTRIMADERM-FLUCONAZOLE COMBI-PACK | TARO PHARMACEUTICALS INC | Kit; Cream; Capsule | FLUCONAZOLE 150 MG; CLOTRIMAZOLE 1 % | Cancelled Post Market |
| 02323419 | CO FLUCONAZOLE-150 | COBALT PHARMACEUTICALS COMPANY | Capsule | FLUCONAZOLE 150 MG | Cancelled Post Market |
| 00891800 | DIFLUCAN | PFIZER CANADA ULC | Tablet | FLUCONAZOLE 50 MG | Cancelled Post Market |
| 00891819 | DIFLUCAN | PFIZER CANADA ULC | Tablet | FLUCONAZOLE 100 MG | Cancelled Post Market |
| 02309432 | DOM-FLUCONAZOLE | DOMINION PHARMACAL | Capsule | FLUCONAZOLE 150 MG | Cancelled Pre Market |
| 02246108 | DOM-FLUCONAZOLE | DOMINION PHARMACAL | Tablet | FLUCONAZOLE 50 MG | Cancelled Post Market |
| 02246109 | DOM-FLUCONAZOLE | DOMINION PHARMACAL | Tablet | FLUCONAZOLE 100 MG | Cancelled Post Market |
| 02301954 | FLUCONAZOLE | SORRES PHARMA INC | Capsule | FLUCONAZOLE 150 MG | Cancelled Post Market |
| 02246942 | FLUCONAZOLE | PHARMEL INC | Capsule | FLUCONAZOLE 150 MG | Cancelled Pre Market |
| 02301946 | FLUCONAZOLE | SORRES PHARMA INC | Tablet | FLUCONAZOLE 100 MG | Cancelled Post Market |
| 02301938 | FLUCONAZOLE | SORRES PHARMA INC | Tablet | FLUCONAZOLE 50 MG | Cancelled Post Market |
| 02248731 | FLUCONAZOLE INJECTION | FRESENIUS KABI CANADA LTD | Solution | FLUCONAZOLE 2 MG | Cancelled Pre Market |
| 02248443 | FLUCONAZOLE INJECTION | SANDOZ CANADA INCORPORATED | Solution | FLUCONAZOLE 2 MG | Cancelled Post Market |
| 02247922 | FLUCONAZOLE INJECTION | TEVA CANADA LIMITED | Solution | FLUCONAZOLE 2 MG | Cancelled Post Market |
| 02247749 | FLUCONAZOLE OMEGA | OMEGA LABORATORIES LIMITED | Solution | FLUCONAZOLE 2 MG | Cancelled Post Market |
| 02340046 | FLUCONAZOLE-150 | PHARMASCIENCE INC | Capsule | FLUCONAZOLE 150 MG | Cancelled Post Market |
| 02432471 | JAMP-FLUCONAZOLE | JAMP PHARMA CORPORATION | Capsule | FLUCONAZOLE 150 MG | Dormant |
| 02378302 | MONICURE | INSIGHT PHARMACEUTICALS, LLC | Capsule | FLUCONAZOLE 150 MG | Cancelled Post Market |
| 02382628 | MONICURE COMBO | INSIGHT PHARMACEUTICALS, LLC | Capsule; Cream; Kit | FLUCONAZOLE 150 MG; MICONAZOLE NITRATE 2 % | Cancelled Post Market |
| 02245697 | MYLAN-FLUCONAZOLE | MYLAN PHARMACEUTICALS ULC | Capsule | FLUCONAZOLE 150 MG | Dormant |
| 02236980 | NOVO-FLUCONAZOLE | TEVA CANADA LIMITED | Tablet | FLUCONAZOLE 150 MG | Cancelled Pre Market |
| 02243645 | NOVO-FLUCONAZOLE-150 | NOVOPHARM LIMITED | Capsule | FLUCONAZOLE 150 MG | Cancelled Post Market |
| 02336162 | NU-FLUCONAZOLE-150 | NU-PHARM INC | Capsule | FLUCONAZOLE 150 MG | Cancelled (Unreturned Annual) |
| 02294044 | PHL-FLUCONAZOLE | PHARMEL INC | Capsule | FLUCONAZOLE 150 MG | Cancelled Post Market |
| 02294036 | PHL-FLUCONAZOLE | PHARMEL INC | Tablet | FLUCONAZOLE 100 MG | Cancelled Pre Market |
| 02282348 | PMS-FLUCONAZOLE | PHARMASCIENCE INC | Capsule | FLUCONAZOLE 150 MG | Cancelled Post Market |
| 02246620 | PMS-FLUCONAZOLE-150 | PHARMASCIENCE INC | Capsule | FLUCONAZOLE 150 MG | Dormant |
| 02310694 | PRO-FLUCONAZOLE | PRO DOC LIMITEE | Capsule | FLUCONAZOLE 150 MG | Cancelled Post Market |
| 02271516 | RIVA-FLUCONAZOLE | LABORATOIRE RIVA INC. | Tablet | FLUCONAZOLE 100 MG | Cancelled Post Market |
| 02249308 | TARO-FLUCONAZOLE | TARO PHARMACEUTICALS INC | Tablet | FLUCONAZOLE 100 MG | Dormant |
| 02249294 | TARO-FLUCONAZOLE | TARO PHARMACEUTICALS INC | Tablet | FLUCONAZOLE 50 MG | Dormant |
| 02236979 | TEVA-FLUCONAZOLE | TEVA CANADA LIMITED | Tablet | FLUCONAZOLE 100 MG | Cancelled Post Market |
| 02236978 | TEVA-FLUCONAZOLE | TEVA CANADA LIMITED | Tablet | FLUCONAZOLE 50 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 23456 | 2020-04-16 | Abbreviated New Drug Submission (ANDS) | UPDATED LABELLING MATERIALS AND MERGER-BUYOUT |
| 16185 | 2014-10-16 | Abbreviated New Drug Submission (ANDS) | MANUFACTURER AND PRODUCT NAME CHANGE |
| 8011 | 2006-06-05 | Abbreviated New Drug Submission (ANDS) |
International API supply for FLUCONAZOLE
9 valid EDQM Certificates of Suitability from 9 holders. 15 active FDA Drug Master Files.
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