← FDA Drug Approvals (Drugs@FDA)
LURASIDONE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ALKEM LABS LTD · Approved 2022-12-13
Drug application
- FDA Application #
ANDA212244- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- LURASIDONE HYDROCHLORIDE
- Generic name
- LURASIDONE HYDROCHLORIDE
- Active ingredients
- LURASIDONE HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- ALKEM LABS LTD
- Manufacturer
- Ascend Laboratories, LLC
- First approval
- 2022-12-13
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown