← FDA Drug Approvals (Drugs@FDA)
ZILEUTON
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: RISING · Approved 2017-03-17
Drug application
- FDA Application #
ANDA204929- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- ZILEUTON
- Generic name
- ZILEUTON
- Active ingredients
- ZILEUTON
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- RISING
- Manufacturer
- Rising Pharma Holdings, Inc.
- First approval
- 2017-03-17
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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