FDA application evidence
ANDA218417
DEXTROMETHORPHAN POLISTIREX
Application summary
- Application number
- ANDA218417
- Sponsor
- AUROBINDO PHARMA LTD
- Product / brand name
- DEXTROMETHORPHAN POLISTIREX
- Active ingredients
- DEXTROMETHORPHAN POLISTIREX
- Submission type
- ORIG
- Submission status
- AP
- Submission date
- 20260415
- Review priority
- STANDARD
- Dosage form
- SUSPENSION, EXTENDED RELEASE
- Route
- ORAL
- Marketing status
- Over-the-counter