← FDA Drug Approvals (Drugs@FDA)
ABACAVIR; DOLUTEGRAVIR; LAMIVUDINE
NDA · New Drug Application · Sponsor: AUROBINDO PHARMA USA · Approved 2023-08-14
Drug application
- FDA Application #
NDA217070
- Application type
- New Drug Application
- Brand name
- ABACAVIR; DOLUTEGRAVIR; LAMIVUDINE
- Generic name
- Abacavir
- Active ingredients
- ABACAVIR; DOLUTEGRAVIR; LAMIVUDINE
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- None (Tentative Approval)
- Sponsor
- AUROBINDO PHARMA USA
- First approval
- 2023-08-14
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown