Application 212338
- Type
- ANDA
- Sponsor
- MACLEODS PHARMS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | METFORMIN HYDROCHLORIDE AND SITAGLIPTIN PHOSPHATE | METFORMIN HYDROCHLORIDE || SITAGLIPTIN | TABLET:FILM COATED | 50MG | No | No |
| 002 | METFORMIN HYDROCHLORIDE AND SITAGLIPTIN PHOSPHATE | METFORMIN HYDROCHLORIDE || SITAGLIPTIN | TABLET;FILM COATED | 500MG | No | No |
| 003 | METFORMIN HYDROCHLORIDE AND SITAGLIPTIN PHOSPHATE | METFORMIN HYDROCHLORIDE || SITAGLIPTIN | TABLET;FILM COATED | 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 |
|---|
| 81275 | ORIG | 2025-02-19 |