FDA application evidence
ANDA215411
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE
Application summary
- Application number
- ANDA215411
- Sponsor
- INVENTIA HEALTHCARE LIMITED
- Product / brand name
- SITAGLIPTIN AND METFORMIN HYDROCHLORIDE
- Active ingredients
- SITAGLIPTIN, METFORMIN HYDROCHLORIDE
- Submission type
- ORIG
- Submission status
- TA
- Submission date
- 20260507
- Review priority
- STANDARD
- Dosage form
- TABLET
- Marketing status
- None (Tentative Approval)