NDC 55150-928
Dactinomycin 0.5 mg per 1 mL injection, powder, lyophilized, for solution
On the label: AuroMedics Pharma LLC.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| EUGIA Pharma Specialities Limited | Medchal-Malkajgiri, India | Makes it, tests it and packages it | No problems foundJul 26, 2023 · 2 inspections |
| Mylan Laboratories Limited | Bangalore, India | Makes it, tests it, packages it, labels it and sterilizes it | Problems found, fixed voluntarilyMay 27, 2022 · 5 inspections, 1 with FDA action |
Product details
- Generic drug
- Dactinomycin: every company that makes it
- Form
- injection, powder, lyophilized, for solution, intravenous
- Strength
- 0.5 mg per 1 mL
- Approval
- ANDA ANDA203385
- On the market since
- Mar 15, 2021
- Package NDCs
55150-928-02- Official label
- DailyMed (National Library of Medicine), updated Jun 18, 2024
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