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EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: LAURUS · Approved 2019-07-26
Drug application
- FDA Application #
ANDA212114- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
- Generic name
- EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
- Active ingredients
- EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- LAURUS
- Manufacturer
- Laurus Labs Limited
- First approval
- 2019-07-26
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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