← FDA Drug Approvals (Drugs@FDA)
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: CHARTWELL RX · Approved 2021-06-04
Drug application
- FDA Application #
ANDA204131
- 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
- CHARTWELL RX
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- First approval
- 2021-06-04
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown