← FDA Drug Approvals (Drugs@FDA)
DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
NDA · New Drug Application · Sponsor: EMCURE PHARMS LTD · Approved 2023-07-12
Drug application
- FDA Application #
NDA211868- Application type
- New Drug Application
- Brand name
- DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
- Generic name
- Dolutegravir
- Active ingredients
- DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- None (Tentative Approval)
- Sponsor
- EMCURE PHARMS LTD
- First approval
- 2023-07-12
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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