GEMCITABINE FOR INJECTION, USP DIN 02318741
Status: Cancelled Post Market
Holder: HOSPIRA HEALTHCARE ULC
Molecule: GEMCITABINE (GEMCITABINE HYDROCHLORIDE)
Health Canada record
| Active ingredient(s) | GEMCITABINE (GEMCITABINE HYDROCHLORIDE) 2 G |
|---|---|
| Dosage form | Powder For Solution |
| Route | Intravenous |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | L01BC05 GEMCITABINE |
| Original market date | 01-Oct-2009 |
| Current status date | 01-Aug-2018 |
| Source | Health Canada DPD |
Establishment licence of the holder
Hospira Healthcare India Pvt. Ltd. — licence , not currently licensed, last inspection rating NC (2017-07-10).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing GEMCITABINE (GEMCITABINE HYDROCHLORIDE)
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02412071 | GEMCITABINE FOR INJECTION | FRESENIUS KABI CANADA LTD | Powder For Solution | GEMCITABINE (GEMCITABINE HYDROCHLORIDE) 200 MG | Approved |
| 02412101 | GEMCITABINE FOR INJECTION | FRESENIUS KABI CANADA LTD | Powder For Solution | GEMCITABINE (GEMCITABINE HYDROCHLORIDE) 2 G | Approved |
| 02412098 | GEMCITABINE FOR INJECTION | FRESENIUS KABI CANADA LTD | Powder For Solution | GEMCITABINE (GEMCITABINE HYDROCHLORIDE) 1 G | Approved |
| 02409925 | GEMCITABINE FOR INJECTION USP | GENERIC MEDICAL PARTNERS INC | Powder For Solution | GEMCITABINE (GEMCITABINE HYDROCHLORIDE) 200 MG | Approved |
| 02409933 | GEMCITABINE FOR INJECTION USP | GENERIC MEDICAL PARTNERS INC | Powder For Solution | GEMCITABINE (GEMCITABINE HYDROCHLORIDE) 1 G | Approved |
| 02412292 | GEMCITABINE INJECTION | SANDOZ CANADA INCORPORATED | Solution | GEMCITABINE (GEMCITABINE HYDROCHLORIDE) 40 MG | Marketed |
| 02565641 | GEMCITABINE INJECTION | HIKMA CANADA LIMITED | Solution | GEMCITABINE (GEMCITABINE HYDROCHLORIDE) 38 MG | Approved |
| 02455382 | GEMCITABINE INJECTION | APOTEX INC | Solution | GEMCITABINE (GEMCITABINE HYDROCHLORIDE) 38 MG | Approved |
| 02402831 | GEMCITABINE INJECTION | PFIZER CANADA ULC | Solution | GEMCITABINE (GEMCITABINE HYDROCHLORIDE) 38 MG | Marketed |
| 02433117 | ACT GEMCITABINE | ACTAVIS PHARMA COMPANY | Solution | GEMCITABINE (GEMCITABINE HYDROCHLORIDE) 38 MG | Cancelled Post Market |
| 02436191 | ACT GEMCITABINE | ACTAVIS PHARMA COMPANY | Powder For Solution | GEMCITABINE (GEMCITABINE HYDROCHLORIDE) 200 MG | Cancelled Pre Market |
| 02436205 | ACT GEMCITABINE | ACTAVIS PHARMA COMPANY | Powder For Solution | GEMCITABINE (GEMCITABINE HYDROCHLORIDE) 1 G | Cancelled Pre Market |
| 02409054 | AJ-GEMCITABINE | AGILA JAMP CANADA INC | Powder For Solution | GEMCITABINE (GEMCITABINE HYDROCHLORIDE) 200 MG | Cancelled Pre Market |
| 02409062 | AJ-GEMCITABINE | AGILA JAMP CANADA INC | Powder For Solution | GEMCITABINE (GEMCITABINE HYDROCHLORIDE) 1 G | Cancelled Pre Market |
| 02409070 | AJ-GEMCITABINE | AGILA JAMP CANADA INC | Powder For Solution | GEMCITABINE (GEMCITABINE HYDROCHLORIDE) 2 G | Cancelled Pre Market |
| 02402858 | GEMCITABINE FOR INJECTION | TELIP, LLC, A SUBSIDIARY OF TELIGENT, INC. | Powder For Solution | GEMCITABINE (GEMCITABINE HYDROCHLORIDE) 200 MG | Cancelled Pre Market |
| 02370034 | GEMCITABINE FOR INJECTION | ACCORD HEALTHCARE INC | Powder For Solution | GEMCITABINE (GEMCITABINE HYDROCHLORIDE) 2 G | Cancelled Post Market |
| 02324210 | GEMCITABINE FOR INJECTION | ACCORD HEALTHCARE INC | Powder For Solution | GEMCITABINE (GEMCITABINE HYDROCHLORIDE) 1 G | Cancelled Post Market |
| 02324202 | GEMCITABINE FOR INJECTION | ACCORD HEALTHCARE INC | Powder For Solution | GEMCITABINE (GEMCITABINE HYDROCHLORIDE) 200 MG | Cancelled Post Market |
| 02305534 | GEMCITABINE FOR INJECTION | TEVA CANADA LIMITED | Powder For Solution | GEMCITABINE (GEMCITABINE HYDROCHLORIDE) 1 G | Cancelled Post Market |
| 02305526 | GEMCITABINE FOR INJECTION | TEVA CANADA LIMITED | Powder For Solution | GEMCITABINE (GEMCITABINE HYDROCHLORIDE) 200 MG | Cancelled Post Market |
| 02402866 | GEMCITABINE FOR INJECTION | TELIP, LLC, A SUBSIDIARY OF TELIGENT, INC. | Powder For Solution | GEMCITABINE (GEMCITABINE HYDROCHLORIDE) 1 G | Cancelled Pre Market |
| 02423510 | GEMCITABINE FOR INJECTION CONCENTRATE | ACCORD HEALTHCARE INC | Solution | GEMCITABINE (GEMCITABINE HYDROCHLORIDE) 100 MG | Cancelled Post Market |
| 02437163 | GEMCITABINE FOR INJECTION, USP | DR REDDY'S LABORATORIES LTD | Powder | GEMCITABINE (GEMCITABINE HYDROCHLORIDE) 1 G | Cancelled Pre Market |
| 02437171 | GEMCITABINE FOR INJECTION, USP | DR REDDY'S LABORATORIES LTD | Powder | GEMCITABINE (GEMCITABINE HYDROCHLORIDE) 2 G | Cancelled Pre Market |
| 02298775 | GEMCITABINE FOR INJECTION, USP | HOSPIRA HEALTHCARE ULC | Powder For Solution | GEMCITABINE (GEMCITABINE HYDROCHLORIDE) 200 MG | Cancelled Post Market |
| 02437155 | GEMCITABINE FOR INJECTION, USP | DR REDDY'S LABORATORIES LTD | Powder | GEMCITABINE (GEMCITABINE HYDROCHLORIDE) 200 MG | Cancelled Pre Market |
| 02407302 | GEMCITABINE FOR INJECTION, USP | MYLAN PHARMACEUTICALS ULC | Powder For Solution | GEMCITABINE (GEMCITABINE HYDROCHLORIDE) 1 G | Cancelled Post Market |
| 02298783 | GEMCITABINE FOR INJECTION, USP | HOSPIRA HEALTHCARE ULC | Powder For Solution | GEMCITABINE (GEMCITABINE HYDROCHLORIDE) 1 G | Cancelled Post Market |
| 02407299 | GEMCITABINE FOR INJECTION, USP | MYLAN PHARMACEUTICALS ULC | Powder For Solution | GEMCITABINE (GEMCITABINE HYDROCHLORIDE) 200 MG | Cancelled Pre Market |
| 02407310 | GEMCITABINE FOR INJECTION, USP | MYLAN PHARMACEUTICALS ULC | Powder For Solution | GEMCITABINE (GEMCITABINE HYDROCHLORIDE) 2 G | Cancelled Post Market |
| 02302101 | GEMCITABINE HYDROCHLORIDE FOR INJECTION | SANDOZ CANADA INCORPORATED | Powder For Solution | GEMCITABINE (GEMCITABINE HYDROCHLORIDE) 1 G | Cancelled Post Market |
| 02302098 | GEMCITABINE HYDROCHLORIDE FOR INJECTION | SANDOZ CANADA INCORPORATED | Powder For Solution | GEMCITABINE (GEMCITABINE HYDROCHLORIDE) 200 MG | Cancelled Post Market |
| 02555468 | GEMCITABINE INJECTION | JUNO PHARMACEUTICALS CORP. | Solution | GEMCITABINE (GEMCITABINE HYDROCHLORIDE) 38 MG | Cancelled Pre Market |
| 02373173 | GEMCITABINE SUN FOR INJECTION | TARO PHARMACEUTICALS INC | Powder For Solution | GEMCITABINE (GEMCITABINE HYDROCHLORIDE) 200 MG | Cancelled Post Market |
| 02373181 | GEMCITABINE SUN FOR INJECTION | TARO PHARMACEUTICALS INC | Powder For Solution | GEMCITABINE (GEMCITABINE HYDROCHLORIDE) 1 G | Cancelled Post Market |
| 02230309 | GEMZAR (1GM/VIAL) | ELI LILLY CANADA INC | Powder For Solution | GEMCITABINE (GEMCITABINE HYDROCHLORIDE) 1 G | Cancelled Post Market |
| 02230308 | GEMZAR (200MG/VIAL) | ELI LILLY CANADA INC | Powder For Solution | GEMCITABINE (GEMCITABINE HYDROCHLORIDE) 200 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 9870 | 2008-11-05 | Supplement to an Abbreviated New Drug Submission (SANDS) | NEW PRESENTATION |