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DOLUTEGRAVIR, LAMIVUDINE, AND TENOFOVIR DISOPROXIL FUMARATE
NDA · New Drug Application · Sponsor: MYLAN PHARMS INC · Approved 2017-08-02
Drug application
- FDA Application #
NDA209670- 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
- MYLAN PHARMS INC
- First approval
- 2017-08-02
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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