HYDROMORPHONE HYDROCHLORIDE INJECTION USP DIN 02561603
Health Canada record
| Active ingredient(s) | HYDROMORPHONE HYDROCHLORIDE 20 MG |
|---|---|
| Dosage form | Solution |
| Route | Intravenous |
| Schedule | NARCOTICS (CDSA I) |
| Class | Human |
| ATC | N02AA03 HYDROMORPHONE |
| Original market date | 18-Jun-2026 |
| Current status date | 18-Jun-2026 |
| Source | Health Canada DPD |
Establishment licence of the holder
Sterinova Inc — licence 102212, currently licensed, last inspection rating I (2026-04-29).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing HYDROMORPHONE HYDROCHLORIDE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02364158 | APO-HYDROMORPHONE | APOTEX INC | Tablet | HYDROMORPHONE HYDROCHLORIDE 8 MG | Marketed |
| 02364123 | APO-HYDROMORPHONE | APOTEX INC | Tablet | HYDROMORPHONE HYDROCHLORIDE 2 MG | Marketed |
| 02364131 | APO-HYDROMORPHONE | APOTEX INC | Tablet | HYDROMORPHONE HYDROCHLORIDE 4 MG | Marketed |
| 02364115 | APO-HYDROMORPHONE | APOTEX INC | Tablet | HYDROMORPHONE HYDROCHLORIDE 1 MG | Marketed |
| 00705438 | DILAUDID | PURDUE PHARMA | Tablet | HYDROMORPHONE HYDROCHLORIDE 1 MG | Marketed |
| 00125083 | DILAUDID | PURDUE PHARMA | Tablet | HYDROMORPHONE HYDROCHLORIDE 2 MG | Marketed |
| 00125121 | DILAUDID | PURDUE PHARMA | Tablet | HYDROMORPHONE HYDROCHLORIDE 4 MG | Marketed |
| 00786543 | DILAUDID | PURDUE PHARMA | Tablet | HYDROMORPHONE HYDROCHLORIDE 8 MG | Marketed |
| 02359510 | HYDROMORPH CONTIN | PURDUE PHARMA | Capsule (Sustained-Release) | HYDROMORPHONE HYDROCHLORIDE 9 MG | Marketed |
| 02359502 | HYDROMORPH CONTIN | PURDUE PHARMA | Capsule (Sustained-Release) | HYDROMORPHONE HYDROCHLORIDE 4.5 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 |
| 02085895 | DILAUDID | PURDUE PHARMA | Powder For Solution | HYDROMORPHONE HYDROCHLORIDE 250 MG | Cancelled Post Market |
| 00786535 | DILAUDID | PURDUE PHARMA | Liquid | HYDROMORPHONE HYDROCHLORIDE 1 MG | Cancelled Post Market |
| 00627100 | DILAUDID | PURDUE PHARMA | Liquid | HYDROMORPHONE HYDROCHLORIDE 2 MG | Cancelled Post Market |
| 00125105 | DILAUDID | PURDUE PHARMA | Suppository | HYDROMORPHONE HYDROCHLORIDE 3 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 |
| 02249936 | HYDROMORPHONE | SORRES PHARMA INC | Tablet | HYDROMORPHONE HYDROCHLORIDE 4 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 |
| 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 |
| 02382636 | HYDROMORPHONE HYDROCHLORIDE INJECTION USP | PFIZER CANADA ULC | Solution | HYDROMORPHONE HYDROCHLORIDE 10 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 |
| 02337290 | JURNISTA | JANSSEN INC | Tablet (Extended-Release) | HYDROMORPHONE HYDROCHLORIDE 32 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 |
| 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 |
| 02319446 | TEVA-HYDROMORPHONE | TEVA CANADA LIMITED | Tablet | HYDROMORPHONE HYDROCHLORIDE 8 MG | Cancelled Post Market |
| 02319438 | TEVA-HYDROMORPHONE | TEVA CANADA LIMITED | Tablet | HYDROMORPHONE HYDROCHLORIDE 4 MG | Cancelled Post Market |
| 02319411 | TEVA-HYDROMORPHONE | TEVA CANADA LIMITED | Tablet | HYDROMORPHONE HYDROCHLORIDE 2 MG | Cancelled Post Market |
| 02319403 | TEVA-HYDROMORPHONE | TEVA CANADA LIMITED | Tablet | HYDROMORPHONE HYDROCHLORIDE 1 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 36343 | 2025-11-07 | Supplement to an Abbreviated New Drug Submission (SANDS) | Addition of new strength: addition of 0.2 mg/mL strength, ready to use format for the Hydromorphone Hydrochloride Injection USP (in 100 mL flexible plastic containers) Update to Prescribing Information (to align with CRP approved Prescribing Information) Update to Prescribing Information (to align with supporting Prescribing Information) |
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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