NDC 47335-936
leuprolide acetate 5 mg per 1 mL / 0.7 mL per 1 mL kit
On the label: Caraco Pharmaceutical Laboratories, Ltd..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Sun Pharmaceutical Industries Limited | Halol, India | Makes it and tests it | Serious problems, FDA actionJun 13, 2025 · 12 inspections, 5 with FDA action |
Product details
- Generic drug
- Isopropyl Alcohol and Leuprolide: every company that makes it
- Form
- kit
- Strength
- 5 mg per 1 mL / 0.7 mL per 1 mL
- Approval
- ANDA ANDA078885
- On the market since
- Dec 15, 2014
- Package NDCs
47335-936-40- Official label
- DailyMed (National Library of Medicine), updated Apr 24, 2026
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