NDC 68083-112
Amiodarone hydrochloride 50 mg per 1 mL injection, solution
On the label: Gland Pharma Limited.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Gland Pharma Limited | Hyderabad, India | Makes it, tests it and packages it | Problems found, fixed voluntarilyJul 25, 2024 · 7 inspections |
Product details
- Generic drug
- Amiodarone: every company that makes it
- Form
- injection, solution, intravenous
- Strength
- 50 mg per 1 mL
- Approval
- ANDA ANDA077161
- On the market since
- Jul 15, 2013
- Package NDCs
68083-112-01- Official label
- DailyMed (National Library of Medicine), updated Aug 26, 2021
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