# DOLUTEGRAVIR SODIUM
> **NDA214566** · New Drug Application · Sponsor: MACLEODS PHARMS LTD · Approved 2021-03-16
## Drug
- **FDA Application Number:** NDA214566
- **Application type:** New Drug Application
- **Brand name:** DOLUTEGRAVIR SODIUM
- **Generic name:** Dolutegravir Sodium
- **Active ingredients:** DOLUTEGRAVIR SODIUM
- **Dosage form:** TABLET
- **Route:** ORAL SUSPENSION
- **Marketing status:** None (Tentative Approval)
- **Sponsor:** MACLEODS PHARMS LTD
- **First approval:** 2021-03-16
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214566)
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*MORVS · CC0 1.0*