Drug application
DOLUTEGRAVIR, LAMIVUDINE and TENOFOVIR DISOPROXIL FUMARATE (DOLUTEGRAVIR, LAMIVUDINE, TENOFOVIR DISOPROXIL FUMARATE)
Drugs@FDA NDA 219804 · ASPEN SA OPERATIONS (PTY) LTD
Key facts
| Drug name | DOLUTEGRAVIR, LAMIVUDINE and TENOFOVIR DISOPROXIL FUMARATE |
|---|---|
| Active ingredients | DOLUTEGRAVIR, LAMIVUDINE, TENOFOVIR DISOPROXIL FUMARATE |
| Application type | NDA |
| Application number | 219804 |
| Company | ASPEN SA OPERATIONS (PTY) LTD |
| Dosage forms | TABLET, ORAL |
| Strength | 50MG/300MG/300MG |
| Marketing status | None (Tentative Approval) |
| Reference listed drug | No |
| Latest submission class | Type 4 - New Combination |
| Latest submission status date | May 7, 2026 |
At a glance
- 1–9 Submissions
- 1–9 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: