← FDA Drug Approvals (Drugs@FDA)
RIVAROXABAN
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MACLEODS PHARMS LTD · Approved 2025-05-14
Drug application
- FDA Application #
ANDA213114- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- RIVAROXABAN
- Generic name
- RIVAROXABAN
- Active ingredients
- RIVAROXABAN
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- MACLEODS PHARMS LTD
- Manufacturer
- Macleods Pharmaceuticals Limited
- First approval
- 2025-05-14
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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