← FDA Drug Approvals (Drugs@FDA)
DOLUTEGRAVIR, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE
NDA · New Drug Application · Sponsor: SHANGHAI DESANA BIO-PHARMACEUTICALS CO LTD · Approved 2020-10-06
Drug application
- FDA Application #
NDA213556
- Application type
- New Drug Application
- Brand name
- DOLUTEGRAVIR, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE
- Generic name
- Dolutegravir
- Active ingredients
- DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- None (Tentative Approval)
- Sponsor
- SHANGHAI DESANA BIO-PHARMACEUTICALS CO LTD
- First approval
- 2020-10-06
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown