GLYCOPYRROLATE INJECTION USP DIN 02473895
Health Canada record
| Active ingredient(s) | GLYCOPYRROLATE 0.4 MG |
|---|---|
| Dosage form | Solution |
| Route | Intravenous; Intramuscular |
| Schedule | ETHICAL |
| Class | Human |
| ATC | A03AB02 GLYCOPYRRONIUM |
| Original market date | 26-May-2021 |
| Current status date | 26-May-2021 |
| Source | Health Canada DPD |
Establishment licence of the holder
Sterimax Inc — licence 100925, currently licensed, last inspection rating C (2024-05-13).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing GLYCOPYRROLATE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02469332 | CUVPOSA | MEDEXUS PHARMACEUTICALS INC. | Solution | GLYCOPYRROLATE 1 MG | Marketed |
| 02382857 | GLYCOPYRROLATE INJECTION | OMEGA LABORATORIES LIMITED | Liquid | GLYCOPYRROLATE 0.2 MG | Marketed |
| 02479273 | GLYCOPYRROLATE INJECTION MULTIDOSE | MONT-PHARMA INC | Solution | GLYCOPYRROLATE 4 MG | Approved |
| 02382849 | GLYCOPYRROLATE INJECTION MULTIDOSE | OMEGA LABORATORIES LIMITED | Solution | GLYCOPYRROLATE 0.2 MG | Marketed |
| 02513749 | GLYCOPYRROLATE INJECTION USP | JAMP PHARMA CORPORATION | Solution | GLYCOPYRROLATE 0.2 MG | Marketed |
| 02039508 | GLYCOPYRROLATE INJECTION USP | SANDOZ CANADA INCORPORATED | Solution | GLYCOPYRROLATE 0.2 MG | Marketed |
| 02473879 | GLYCOPYRROLATE INJECTION USP | STERIMAX INC | Solution | GLYCOPYRROLATE 0.2 MG | Marketed |
| 02473887 | GLYCOPYRROLATE INJECTION USP | STERIMAX INC | Solution | GLYCOPYRROLATE 4 MG | Marketed |
| 02532379 | GLYCOPYRROLATE INJECTION USP | JAMP PHARMA CORPORATION | Solution | GLYCOPYRROLATE 0.2 MG | Marketed |
| 02539160 | GLYCOPYRROLATE INJECTION | JUNO PHARMACEUTICALS CORP. | Solution | GLYCOPYRROLATE 0.2 MG | Cancelled Pre Market |
| 02539276 | GLYCOPYRROLATE INJECTION MULTIDOSE | JUNO PHARMACEUTICALS CORP. | Solution | GLYCOPYRROLATE 0.2 MG | Cancelled Pre Market |
| 01919474 | ROBINUL FORTE TAB 2MG | AYERST LABORATORIES | Tablet | GLYCOPYRROLATE 2 MG | Cancelled Post Market |
| 02043602 | ROBINUL TAB 1MG | WYETH-AYERST CANADA INC. | Tablet | GLYCOPYRROLATE 1 MG | Cancelled Post Market |
| 02043629 | ROBINUL-FORTE TAB 2MG | WYETH-AYERST CANADA INC. | Tablet | GLYCOPYRROLATE 2 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 20601 | 2018-03-12 | Abbreviated New Drug Submission (ANDS) |
International API supply for GLYCOPYRROLATE
16 active FDA Drug Master Files.
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