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EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: CIPLA LIMITED · Approved 2012-02-27
Drug application
- FDA Application #
ANDA091593- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
- Generic name
- Efavirenz
- Active ingredients
- EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- None (Tentative Approval)
- Sponsor
- CIPLA LIMITED
- First approval
- 2012-02-27
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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