← FDA Drug Approvals (Drugs@FDA)
DABIGATRAN ETEXILATE MESYLATE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ALKEM LABS LTD · Approved 2020-03-11
Drug application
- FDA Application #
ANDA208040- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- DABIGATRAN ETEXILATE MESYLATE
- Generic name
- DABIGATRAN ETEXILATE
- Active ingredients
- DABIGATRAN ETEXILATE MESYLATE
- Dosage form
- CAPSULE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- ALKEM LABS LTD
- Manufacturer
- Major Pharmaceuticals
- First approval
- 2020-03-11
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown