← FDA Drug Approvals (Drugs@FDA)
RANOLAZINE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: UMEDICA · Approved 2026-08-05
Drug application
- FDA Application #
ANDA214551- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- RANOLAZINE
- Generic name
- RANOLAZINE
- Active ingredients
- RANOLAZINE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- UMEDICA
- Manufacturer
- Umedica Laboratories USA Inc.
- First approval
- 2026-08-05
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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