← FDA Drug Approvals (Drugs@FDA)
ASPRUZYO SPRINKLE
NDA · New Drug Application · Sponsor: SPIL · Approved 2022-02-28
Drug application
- FDA Application #
NDA216018- Application type
- New Drug Application
- Brand name
- ASPRUZYO SPRINKLE
- Generic name
- RANOLAZINE
- Active ingredients
- RANOLAZINE
- Dosage form
- GRANULE, EXTENDED RELEASE
- Route
- ORAL
- Marketing status
- Discontinued
- Sponsor
- SPIL
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES, INC.
- First approval
- 2022-02-28
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown