Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Dr.reddy's Laboratories Limited | Visakhapatnam, India | Makes it and tests it | Problems found, fixed voluntarilyMay 17, 2024 · 9 inspections, 2 with FDA action |
| Hetero Labs Limited | Hyderabad, India | Makes it | Problems found, fixed voluntarilyJul 21, 2023 · 8 inspections |
Recalls
- Feb 17, 2021 · Class II · Dr. Reddy's Laboratories, Inc.
Failed Dissolution Specifications
Lots: Lot #: a) H2000206, Exp 06/22; b) H2000138, Exp 06/22
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Imatinib: every company that makes it
- Form
- tablet
- Strength
- 100 mg
- Approval
- ANDA ANDA206547
- On the market since
- Aug 13, 2018
- Package NDCs
43598-344-1043598-344-3043598-344-3143598-344-90- Official label
- DailyMed (National Library of Medicine), updated Apr 20, 2024
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