FUNGIZONE DIN 00029149
Health Canada record
| Active ingredient(s) | AMPHOTERICIN B 50 MG |
|---|---|
| Dosage form | Powder For Solution |
| Route | Intravenous |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | J02AA01 AMPHOTERICIN B |
| Original market date | 31-Dec-1958 |
| Current status date | 02-Jan-2020 |
| Source | Health Canada DPD |
Establishment licence of the holder
Cheplapharm Arzneimittel GmbH — licence , not currently licensed, last inspection rating C (2024-10-10).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing AMPHOTERICIN B
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02241630 | AMBISOME | ASTELLAS PHARMA CANADA INC | Powder For Solution | AMPHOTERICIN B 50 MG | Marketed |
| 02405032 | AMPHOTERICIN B FOR INJECTION, USP | STERIMAX INC | Powder For Solution | AMPHOTERICIN B 50 MG | Approved |
| 02554186 | TARO-AMPHOTERICIN B LIPOSOMAL | TARO PHARMACEUTICALS INC | Powder For Solution | AMPHOTERICIN B 50 MG | Approved |
| 02231590 | ABELCET | LEADIANT BIOSCIENCES, INC | Suspension | AMPHOTERICIN B 5 MG | Cancelled Post Market |
| 02241749 | AMPHOTEC 100 MG | THREE RIVERS PHARMACEUTICALS LLC | Powder For Suspension | AMPHOTERICIN B 100 MG | Cancelled Post Market |
| 02241750 | AMPHOTEC 50 MG | THREE RIVERS PHARMACEUTICALS LLC | Powder For Suspension | AMPHOTERICIN B 50 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 23019 | 2019-12-13 | New Drug Submission (NDS) | CHANGE IN PRODUCT OWNERSHIP |
| 5924 | 2004-11-25 | New Drug Submission (NDS) | MANUFACTURER NAME CHANGE |
International API supply for AMPHOTERICIN B
3 valid EDQM Certificates of Suitability from 3 holders. 6 active FDA Drug Master Files.
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