Discontinuation report RANITIDINE INJECTION USP
| Report ID | 127687 |
| Drug Identification Number | 02256711 |
| Brand name | RANITIDINE INJECTION USP |
| Common or Proper name | RANITIDINE |
| Company Name | SANDOZ CANADA INCORPORATED |
| Market Status | CANCELLED POST MARKET |
| Active Ingredient(s) | RANITIDINE |
| Strength(s) | 50MG |
| Dosage form(s) | SOLUTION |
| Route of administration | INTRAMUSCULAR INTRAVENOUS INTRAMUSCULAR INTRAVENOUS |
| Packaging size | 1 VIAL 50ML |
| ATC code | A02BA |
| ATC description | DRUGS FOR PEPTIC ULCER AND GASTROESOPHAGEAL REFLUX DISEASE (GERD) |
| Reason for discontinuation | Manufacturing issues |
| Anticipated discontinuation date | |
| Actual discontinuation date | 2020-11-02 |
| Remaining supply date | 2020-11-02 |
| Discontinuation status | Discontinued |
| Discontinuation decision reversal | No |
| Information on remaining supply | |
| Company comments | PrFamotidine Omega 10mg/mL as a substitute for PrRanitidine Injection USP 25 mg/mL |
| Health Canada comments | |
| Tier 3 Status | No |
| Contact Address | 4600 RUE ARMAND-FRAPPIER SAINT-HUBERT, QUEBEC CANADA J3Z 1G5 |
| Company contact information | 1 800-361-3062 |
Version History
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| Version Number | Date Updated | Language | |
|---|---|---|---|
| v3 | 2020-11-03 | English | Compare |
| v2 | 2020-11-02 | French | Compare |
| v1 | 2020-11-02 | English | Compare |
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