Orange Book product
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 167MG;250MG
Orange Book ANDA 209721 · AMNEAL PHARMACEUTICALS CO GMBH · Prescription
Key facts
| Proprietary name | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE |
|---|---|
| Active ingredients | EMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATE |
| Strength | 167MG;250MG |
| Dosage form | TABLET |
| Route | ORAL |
| Application | ANDA209721 |
| Applicant holder | AMNEAL PHARMACEUTICALS CO GMBH |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Aug 22, 2018 |
At a glance
- 1–9 Marketed products with the same ingredient, strength and form
- 1–9 Products in this application
- No Reference listed drug
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Orange Book products
The FDA Orange Book lists approved drug products with their therapeutic equivalence (TE) codes, reference listed drugs and marketing status. Products approved before 1982 show an approval date of Jan 1, 1982.