Drug application
DOLUTEGRAVIR, EMTRICITABINE and TENOFOVIR ALAFENAMIDE (DOLUTEGRAVIR, EMTRICITABINE and TENOFOVIR ALAFENAMIDE)
Drugs@FDA NDA 215448 · AUROBINDO PHARMA USA
Key facts
| Drug name | DOLUTEGRAVIR, EMTRICITABINE and TENOFOVIR ALAFENAMIDE |
|---|---|
| Active ingredients | DOLUTEGRAVIR, EMTRICITABINE and TENOFOVIR ALAFENAMIDE |
| Application type | NDA |
| Application number | 215448 |
| Company | AUROBINDO PHARMA USA |
| Dosage forms | TABLET, ORAL |
| Strength | 50MG/200MG/25MG |
| Marketing status | None (Tentative Approval) |
| Reference listed drug | No |
| Latest submission class | Type 4 - New Combination |
| Latest submission status date | May 26, 2023 |
At a glance
- 1–9 Submissions
- None Label versions
- 1–9 Products
- None Therapeutic equivalents
- Yes FDA letters on file
- No FDA reviews on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Drugs@FDA applications
Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.
Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date: