← FDA Drug Approvals (Drugs@FDA)
ZILEUTON
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ANNORA PHARMA · Approved 2022-10-11
Drug application
- FDA Application #
ANDA215742- 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
- ANNORA PHARMA
- Manufacturer
- NorthStar RxLLC
- First approval
- 2022-10-11
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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