← FDA Drug Approvals (Drugs@FDA)
DABIGATRAN ETEXILATE MESYLATE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ALEMBIC · Approved 2024-08-12
Drug application
- FDA Application #
ANDA215233- 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
- ALEMBIC
- Manufacturer
- Alembic Pharmaceuticals Inc.
- First approval
- 2024-08-12
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown