HYDROMORPHONE HYDROCHLORIDE INJECTION USP DIN 02382636
Health Canada record
| Active ingredient(s) | HYDROMORPHONE HYDROCHLORIDE 10 MG |
|---|---|
| Dosage form | Solution |
| Route | Intravenous; Subcutaneous; Intramuscular |
| Schedule | NARCOTICS (CDSA I) |
| Class | Human |
| ATC | N02AA03 HYDROMORPHONE |
| Original market date | 11-Jun-2014 |
| Current status date | 13-Nov-2025 |
| Source | Health Canada DPD |
Establishment licence of the holder
Pfizer Canada ULC — licence 100255, currently licensed, last inspection rating C (2023-08-07).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing HYDROMORPHONE HYDROCHLORIDE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02364131 | APO-HYDROMORPHONE | APOTEX INC | Tablet | HYDROMORPHONE HYDROCHLORIDE 4 MG | Marketed |
| 02364115 | APO-HYDROMORPHONE | APOTEX INC | Tablet | HYDROMORPHONE HYDROCHLORIDE 1 MG | Marketed |
| 02364123 | APO-HYDROMORPHONE | APOTEX INC | Tablet | HYDROMORPHONE HYDROCHLORIDE 2 MG | Marketed |
| 02364158 | APO-HYDROMORPHONE | APOTEX INC | Tablet | HYDROMORPHONE HYDROCHLORIDE 8 MG | Marketed |
| 00786543 | DILAUDID | PURDUE PHARMA | Tablet | HYDROMORPHONE HYDROCHLORIDE 8 MG | Marketed |
| 00125083 | DILAUDID | PURDUE PHARMA | Tablet | HYDROMORPHONE HYDROCHLORIDE 2 MG | Marketed |
| 00125121 | DILAUDID | PURDUE PHARMA | Tablet | HYDROMORPHONE HYDROCHLORIDE 4 MG | Marketed |
| 00705438 | DILAUDID | PURDUE PHARMA | Tablet | HYDROMORPHONE HYDROCHLORIDE 1 MG | Marketed |
| 02359502 | HYDROMORPH CONTIN | PURDUE PHARMA | Capsule (Sustained-Release) | HYDROMORPHONE HYDROCHLORIDE 4.5 MG | Marketed |
| 02359510 | HYDROMORPH CONTIN | PURDUE PHARMA | Capsule (Sustained-Release) | HYDROMORPHONE HYDROCHLORIDE 9 MG | Marketed |
| 02125366 | HYDROMORPH CONTIN-CONTROLLED RELEASE CAP - 12MG | PURDUE PHARMA | Capsule (Sustained-Release) | HYDROMORPHONE HYDROCHLORIDE 12 MG | Marketed |
| 02243562 | HYDROMORPH CONTIN-CONTROLLED RELEASE CAP - 18MG | PURDUE PHARMA | Capsule (Sustained-Release) | HYDROMORPHONE HYDROCHLORIDE 18 MG | Marketed |
| 02125382 | HYDROMORPH CONTIN-CONTROLLED RELEASE CAP - 24MG | PURDUE PHARMA | Capsule (Sustained-Release) | HYDROMORPHONE HYDROCHLORIDE 24 MG | Marketed |
| 02125390 | HYDROMORPH CONTIN-CONTROLLED RELEASE CAP - 30MG | PURDUE PHARMA | Capsule (Sustained-Release) | HYDROMORPHONE HYDROCHLORIDE 30 MG | Marketed |
| 02125323 | HYDROMORPH CONTIN-CONTROLLED RELEASE CAP - 3MG | PURDUE PHARMA | Capsule (Sustained-Release) | HYDROMORPHONE HYDROCHLORIDE 3 MG | Marketed |
| 02125331 | HYDROMORPH CONTIN-CONTROLLED RELEASE CAP - 6MG | PURDUE PHARMA | Capsule (Sustained-Release) | HYDROMORPHONE HYDROCHLORIDE 6 MG | Marketed |
| 02145928 | HYDROMORPHONE HP 10 | SANDOZ CANADA INCORPORATED | Solution | HYDROMORPHONE HYDROCHLORIDE 10 MG | Marketed |
| 02145936 | HYDROMORPHONE HP 20 | SANDOZ CANADA INCORPORATED | Solution | HYDROMORPHONE HYDROCHLORIDE 20 MG | Marketed |
| 02146126 | HYDROMORPHONE HP 50 | SANDOZ CANADA INCORPORATED | Solution | HYDROMORPHONE HYDROCHLORIDE 50 MG | Marketed |
| 02460602 | HYDROMORPHONE HYDROCHLORIDE INJECTION | STERIMAX INC | Solution | HYDROMORPHONE HYDROCHLORIDE 2 MG | Marketed |
| 02460610 | HYDROMORPHONE HYDROCHLORIDE INJECTION HP 10 | STERIMAX INC | Solution | HYDROMORPHONE HYDROCHLORIDE 10 MG | Marketed |
| 02145901 | HYDROMORPHONE HYDROCHLORIDE INJECTION USP | SANDOZ CANADA INCORPORATED | Solution | HYDROMORPHONE HYDROCHLORIDE 2 MG | Marketed |
| 01916386 | PMS HYDROMORPHONE SIROP 1MG/ML | PHARMASCIENCE INC | Syrup | HYDROMORPHONE HYDROCHLORIDE 1 MG | Marketed |
| 00885444 | PMS-HYDROMORPHONE TAB 1MG | PHARMASCIENCE INC | Tablet | HYDROMORPHONE HYDROCHLORIDE 1 MG | Marketed |
| 00885436 | PMS-HYDROMORPHONE TAB 2MG | PHARMASCIENCE INC | Tablet | HYDROMORPHONE HYDROCHLORIDE 2 MG | Marketed |
| 00885401 | PMS-HYDROMORPHONE TAB 4MG | PHARMASCIENCE INC | Tablet | HYDROMORPHONE HYDROCHLORIDE 4 MG | Marketed |
| 00885428 | PMS-HYDROMORPHONE TAB 8MG | PHARMASCIENCE INC | Tablet | HYDROMORPHONE HYDROCHLORIDE 8 MG | Marketed |
| 02460777 | BAR-HYDROMORPHONE CR | BARD PHARMACEUTICALS (1990) INC | Capsule (Extended-Release) | HYDROMORPHONE HYDROCHLORIDE 3 MG | Cancelled Pre Market |
| 02085895 | DILAUDID | PURDUE PHARMA | Powder For Solution | HYDROMORPHONE HYDROCHLORIDE 250 MG | Cancelled Post Market |
| 00125105 | DILAUDID | PURDUE PHARMA | Suppository | HYDROMORPHONE HYDROCHLORIDE 3 MG | Cancelled Post Market |
| 00627100 | DILAUDID | PURDUE PHARMA | Liquid | HYDROMORPHONE HYDROCHLORIDE 2 MG | Cancelled Post Market |
| 00786535 | DILAUDID | PURDUE PHARMA | Liquid | HYDROMORPHONE HYDROCHLORIDE 1 MG | Cancelled Post Market |
| 00622133 | DILAUDID HP | PURDUE PHARMA | Liquid | HYDROMORPHONE HYDROCHLORIDE 10 MG | Cancelled Post Market |
| 02146118 | DILAUDID-HP-PLUS | PURDUE PHARMA | Solution | HYDROMORPHONE HYDROCHLORIDE 20 MG | Cancelled Post Market |
| 02145863 | DILAUDID-XP | PURDUE PHARMA | Liquid | HYDROMORPHONE HYDROCHLORIDE 50 MG | Cancelled Post Market |
| 02245703 | HYDROMORPH.IR - 2MG | PURDUE PHARMA | Tablet | HYDROMORPHONE HYDROCHLORIDE 2 MG | Cancelled Post Market |
| 02245704 | HYDROMORPH.IR - 4MG | PURDUE PHARMA | Tablet | HYDROMORPHONE HYDROCHLORIDE 4 MG | Cancelled Post Market |
| 02245705 | HYDROMORPH.IR - 8MG | PURDUE PHARMA | Tablet | HYDROMORPHONE HYDROCHLORIDE 8 MG | Cancelled Post Market |
| 02249928 | HYDROMORPHONE | SORRES PHARMA INC | Tablet | HYDROMORPHONE HYDROCHLORIDE 2 MG | Cancelled Post Market |
| 02192144 | HYDROMORPHONE | SORRES PHARMA INC | Tablet | HYDROMORPHONE HYDROCHLORIDE 8 MG | Cancelled Post Market |
| 02192101 | HYDROMORPHONE | SORRES PHARMA INC | Tablet | HYDROMORPHONE HYDROCHLORIDE 1 MG | Cancelled Post Market |
| 02249936 | HYDROMORPHONE | SORRES PHARMA INC | Tablet | HYDROMORPHONE HYDROCHLORIDE 4 MG | Cancelled Post Market |
| 01916289 | HYDROMORPHONE HCL TAB 2MG USP | ROXANE LABS, DIVISION OF BOEHRINGER INGELHEIM | Tablet | HYDROMORPHONE HYDROCHLORIDE 2 MG | Cancelled Post Market |
| 01916270 | HYDROMORPHONE HCL TAB 4MG USP | ROXANE LABS, DIVISION OF BOEHRINGER INGELHEIM | Tablet | HYDROMORPHONE HYDROCHLORIDE 4 MG | Cancelled Post Market |
| 02244797 | HYDROMORPHONE HP FORTE INJECTION | SANDOZ CANADA INCORPORATED | Solution | HYDROMORPHONE HYDROCHLORIDE 1000 MG | Cancelled Post Market |
| 01979914 | HYDROMORPHONE HYDROCHLORIDE SUP 3MG | SANDOZ CANADA INCORPORATED | Suppository | HYDROMORPHONE HYDROCHLORIDE 3 MG | Cancelled Post Market |
| 02337266 | JURNISTA | JANSSEN INC | Tablet (Extended-Release) | HYDROMORPHONE HYDROCHLORIDE 4 MG | Cancelled Post Market |
| 02337274 | JURNISTA | JANSSEN INC | Tablet (Extended-Release) | HYDROMORPHONE HYDROCHLORIDE 8 MG | Cancelled Post Market |
| 02337282 | JURNISTA | JANSSEN INC | Tablet (Extended-Release) | HYDROMORPHONE HYDROCHLORIDE 16 MG | Cancelled Post Market |
| 02337290 | JURNISTA | JANSSEN INC | Tablet (Extended-Release) | HYDROMORPHONE HYDROCHLORIDE 32 MG | Cancelled Post Market |
| 02243159 | PALLADONE XL - 12MG | PURDUE PHARMA | Capsule (Controlled-Delivery) | HYDROMORPHONE HYDROCHLORIDE 12 MG | Cancelled Post Market |
| 02243160 | PALLADONE XL - 16MG | PURDUE PHARMA | Capsule (Controlled-Delivery) | HYDROMORPHONE HYDROCHLORIDE 16 MG | Cancelled Post Market |
| 02243161 | PALLADONE XL - 24MG | PURDUE PHARMA | Capsule (Controlled-Delivery) | HYDROMORPHONE HYDROCHLORIDE 24 MG | Cancelled Post Market |
| 02249901 | PHL-HYDROMORPHONE | PHARMEL INC | Suppository | HYDROMORPHONE HYDROCHLORIDE 3 MG | Cancelled Pre Market |
| 02192136 | PHL-HYDROMORPHONE -SYR 1MG/ML | PHARMEL INC | Syrup | HYDROMORPHONE HYDROCHLORIDE 1 MG | Cancelled Pre Market |
| 01916394 | PMS HYDROMORPHONE SUPPOSITOIRE 3MG | PHARMASCIENCE INC | Suppository | HYDROMORPHONE HYDROCHLORIDE 3 MG | Cancelled Post Market |
| 02319411 | TEVA-HYDROMORPHONE | TEVA CANADA LIMITED | Tablet | HYDROMORPHONE HYDROCHLORIDE 2 MG | Cancelled Post Market |
| 02319438 | TEVA-HYDROMORPHONE | TEVA CANADA LIMITED | Tablet | HYDROMORPHONE HYDROCHLORIDE 4 MG | Cancelled Post Market |
| 02319403 | TEVA-HYDROMORPHONE | TEVA CANADA LIMITED | Tablet | HYDROMORPHONE HYDROCHLORIDE 1 MG | Cancelled Post Market |
| 02319446 | TEVA-HYDROMORPHONE | TEVA CANADA LIMITED | Tablet | HYDROMORPHONE HYDROCHLORIDE 8 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 19756 | 2017-09-05 | Abbreviated New Drug Submission (ANDS) | MERGER - BUYOUT |
| 13162 | 2012-03-28 | Abbreviated New Drug Submission (ANDS) |
International API supply for HYDROMORPHONE HYDROCHLORIDE
7 valid EDQM Certificates of Suitability from 6 holders. 4 active FDA Drug Master Files.
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