FDA application evidence
ANDA208045
LURASIDONE HYDROCHLORIDE
Application summary
- Application number
- ANDA208045
- Sponsor
- AUROBINDO PHARMA LTD
- Product / brand name
- LURASIDONE HYDROCHLORIDE
- Active ingredients
- LURASIDONE HYDROCHLORIDE
- Submission type
- SUPPL
- Submission status
- AP
- Submission date
- 20260515
- Review priority
- STANDARD
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- TE code
- AB