← FDA Drug Approvals (Drugs@FDA)
EMTRICITABINE, RILPIVIRINE AND TENOFOVIR DISOPROXIL FUMARATE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MYLAN · Approved 2025-05-20
Drug application
- FDA Application #
ANDA208452- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- EMTRICITABINE, RILPIVIRINE AND TENOFOVIR DISOPROXIL FUMARATE
- Generic name
- EMTRICITABINE, RILPIVIRINE, TENOFOVIR DISOPROXIL FUMARATE
- Active ingredients
- EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- MYLAN
- Manufacturer
- Mylan Pharmaceuticals Inc.
- First approval
- 2025-05-20
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown