NDC 55111-686
gemcitabine 200 mg per 5 mL injection, powder, lyophilized, for solution
On the label: Dr.Reddy's Laboratories Ltd..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Cipla Limited | Salcette, India | Makes it, tests it and packages it | Problems found, fixed voluntarilyJun 21, 2024 · 12 inspections, 2 with FDA action |
| Dr.reddy's Laboratories Limited | Visakhapatnam, India | Makes it, tests it and packages it | Problems found, fixed voluntarilyMay 17, 2024 · 9 inspections, 2 with FDA action |
| Kindos Pharmaceuticals Co., Ltd. | Chengdu, China | Makes it, tests it and packages it | Problems found, fixed voluntarilyJul 19, 2024 · 6 inspections |
Product details
- Generic drug
- Gemcitabine: every company that makes it
- Form
- injection, powder, lyophilized, for solution, intravenous
- Strength
- 200 mg per 5 mL
- Approval
- ANDA ANDA091365
- On the market since
- Jul 25, 2011
- Package NDCs
55111-686-07- Official label
- DailyMed (National Library of Medicine), updated Sep 9, 2024
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