NIZORAL TABLETS 200MG DIN 00633836
Status: Cancelled Post Market
Holder: MCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INC
Molecule: KETOCONAZOLE
Health Canada record
| Active ingredient(s) | KETOCONAZOLE 200 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | J02AB02 KETOCONAZOLE |
| Original market date | 31-Dec-1984 |
| Current status date | 06-Feb-2003 |
| Source | Health Canada DPD |
Establishment licence of the holder
McNeil Consumer & Specialty Pharmaceuticals — licence , not currently licensed, last inspection rating C (2018-06-12).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing KETOCONAZOLE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02237235 | APO-KETOCONAZOLE | APOTEX INC | Tablet | KETOCONAZOLE 200 MG | Marketed |
| 02122197 | KETOCONAZOLE | APOTEX INC | Tablet | KETOCONAZOLE 200 MG | Approved |
| 02245662 | KETODERM CREAM 2% | TAROPHARMA, A DIVISION OF TARO PHARMACEUTICALS INC. | Cream | KETOCONAZOLE 2 % | Marketed |
| 02182920 | NIZORAL | KRAMER LABORATORIES, INC | Shampoo | KETOCONAZOLE 2 % | Marketed |
| 02231061 | TEVA-KETOCONAZOLE | TEVA CANADA LIMITED | Tablet | KETOCONAZOLE 200 MG | Marketed |
| 00703974 | NIZORAL CREAM 2% | MCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INC | Cream | KETOCONAZOLE 2 % | Cancelled Post Market |
| 00788813 | NIZORAL ORAL SUSPENSION 20MG/ML | JANSSEN PHARMACEUTICA, DIVISION OF JANSSEN-ORTHO INC. | Suspension | KETOCONAZOLE 20 MG | Cancelled Post Market |
| 00803588 | NIZORAL SHP 2% | JANSSEN PHARMACEUTICA, DIVISION OF JANSSEN-ORTHO INC. | Shampoo | KETOCONAZOLE 2 % | Cancelled Post Market |
| 02292661 | XOLEGEL | BARRIER THERAPEUTICS CANADA INC. | Gel | KETOCONAZOLE 2 % | Cancelled (Unreturned Annual) |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 2356 | 2001-01-24 | New Drug Submission (NDS) | MANUFACTURER NAME CHANGE |
| 3890 | 1997-08-18 | New Drug Submission (NDS) |
International API supply for KETOCONAZOLE
4 valid EDQM Certificates of Suitability from 4 holders. 11 active FDA Drug Master Files.
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