Drug application
DOLUTEGRAVIR SODIUM (DOLUTEGRAVIR SODIUM)
Drugs@FDA NDA 214566 · MACLEODS PHARMS LTD
Key facts
| Drug name | DOLUTEGRAVIR SODIUM |
|---|---|
| Active ingredients | DOLUTEGRAVIR SODIUM |
| Application type | NDA |
| Application number | 214566 |
| Company | MACLEODS PHARMS LTD |
| Dosage forms | TABLET, ORAL SUSPENSION |
| Strength | 10MG |
| Marketing status | None (Tentative Approval) |
| Reference listed drug | No |
| Latest submission class | Type 5 - New Formulation or New Manufacturer |
| Latest submission status date | Mar 16, 2021 |
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: