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DABIGATRAN ETEXILATE MESYLATE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MYLAN · Approved 2025-02-03
Drug application
- FDA Application #
ANDA208067- 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
- MYLAN
- Manufacturer
- Mylan Pharmaceuticals Inc.
- First approval
- 2025-02-03
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown