Drug application
DOLUTEGRAVIR; TENOFOVIR DISOPROXIL FUMARATE; LAMIVUDINE (DOLUTEGRAVIR, TENOFOVIR DISOPROXIL FUMARATE, LAMIVUDINE)
Drugs@FDA NDA 217016 · STRIDES PHARMA
Key facts
| Drug name | DOLUTEGRAVIR; TENOFOVIR DISOPROXIL FUMARATE; LAMIVUDINE |
|---|---|
| Active ingredients | DOLUTEGRAVIR, TENOFOVIR DISOPROXIL FUMARATE, LAMIVUDINE |
| Application type | NDA |
| Application number | 217016 |
| Company | STRIDES PHARMA |
| Dosage forms | TABLET, ORAL |
| Strength | 50MG/300MG/300MG |
| Marketing status | None (Tentative Approval) |
| Reference listed drug | No |
| Latest submission class | New Combination and New Formulation or New Manufacturer |
| Latest submission status date | Sep 14, 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: