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EFAVIRENZ, LAMIVUDINE, AND TENOFOVIR DISOPROXIL FUMARATE
NDA · New Drug Application · Sponsor: HETERO DRUGS LTD · Approved 2017-06-30
Drug application
- FDA Application #
NDA204119- Application type
- New Drug Application
- Brand name
- EFAVIRENZ, LAMIVUDINE, AND TENOFOVIR DISOPROXIL FUMARATE
- Generic name
- Efavirenz
- Active ingredients
- EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- None (Tentative Approval)
- Sponsor
- HETERO DRUGS LTD
- First approval
- 2017-06-30
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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