NDC 82009-109
Emtricitabine and Tenofovir Disoproxil Fumarate 200 mg / 300 mg tablet, film coated
On the label: Quallent Pharmaceuticals Health LLC.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Aurobindo Pharma Limited | Medchal, India | Makes it and tests it | Problems found, fixed voluntarilyJul 21, 2023 · 13 inspections, 1 with FDA action |
| Aurobindo Pharma Limited | Mahabubnagar, India | Makes it and tests it | Problems found, fixed voluntarilyMay 10, 2022 · 7 inspections, 1 with FDA action |
Product details
- Generic drug
- Emtricitabine and Tenofovir: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 200 mg / 300 mg
- Approval
- ANDA ANDA090513
- On the market since
- Sep 1, 2023
- Package NDCs
82009-109-30- Official label
- DailyMed (National Library of Medicine), updated Jun 9, 2024
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