Application 218971
- Type
- ANDA
- Sponsor
- MANKIND PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | SITAGLIPTIN AND METFORMIN HCL | SITAGLIPTIN, METFORMIN HYDROCHLORIDE | TABLET | 1000MG ER TABLET | No | No |
| 002 | SITAGLIPTIN AND METFORMIN HCL | SITAGLIPTIN, METFORMIN HYDROCHLORIDE | TABLET | EQ 100MG BASE TABLET | No | No |
| 003 | SITAGLIPTIN AND METFORMIN HCL | SITAGLIPTIN, METFORMIN HYDROCHLORIDE | TABLET | 500MG | No | No |
| 004 | SITAGLIPTIN AND METFORMIN HCL | SITAGLIPTIN, METFORMIN HYDROCHLORIDE | TABLET | 50MG | No | No |
| 005 | SITAGLIPTIN AND METFORMIN HCL | SITAGLIPTIN, METFORMIN HYDROCHLORIDE | TABLET | 1000MG | No | No |
Source provenance: Browse the complete Orange Book source catalog.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 81205 | ORIG | 2025-02-10 |