NDC 71610-609
Simvastatin 20 mg tablet, film coated
On the label: Aphena Pharma Solutions - Tennessee, Inc.. It's repackaged: Aphena Pharma Solutions - Tennessee, Inc. rebottles it from PuraCap Laboratories LLC dba Blu Pharmaceuticals's NDC 24658-502.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Biocon Limited | Bengaluru, India | Makes the active ingredient | Problems found, fixed voluntarilySep 27, 2024 · 3 inspections |
| Caribe Holdings (Cayman) Co. Ltd. DBA PuraCap Caribe | Location not on file | Makes it | Not inspected on record |
Repackaging site
- Aphena Pharma Solutions - Tennessee, LLC, Cookeville, TN, United States · repackages it
Product details
- Generic drug
- Simvastatin: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 20 mg
- Approval
- ANDA ANDA078034
- On the market since
- Dec 17, 2015
- Package NDCs
71610-609-45- Official label
- DailyMed (National Library of Medicine), updated Mar 20, 2023
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