Application 205942
- Type
- ANDA
- Sponsor
- AMNEAL PHARMS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | SAXAGLIPTIN;METFORMIN HYDROCHLORIDE | SAXAGLIPTIN;METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 5MG;500MG | No | No |
| 002 | SAXAGLIPTIN;METFORMIN HYDROCHLORIDE | SAXAGLIPTIN;METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 2.5MG;1000MG | No | No |
| 003 | SAXAGLIPTIN;METFORMIN HYDROCHLORIDE | SAXAGLIPTIN;METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 5MG;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 |
|---|
| 32769 | ORIG | 2016-01-22 |