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DABIGATRAN ETEXILATE MESYLATE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: APOTEX · Approved 2023-12-15
Drug application
- FDA Application #
ANDA208070- 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
- APOTEX
- Manufacturer
- Apotex Corp.
- First approval
- 2023-12-15
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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