Application 208430
- Type
- ANDA
- Sponsor
- MYLAN PHARMS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LINAGLIPTIN; METFORMIN HYDROCHLORIDE | LINAGLIPTIN;METFORMIN HYDROCHLORIDE | TABLET;ORAL | 2.5MG;500MG | No | No |
| 002 | LINAGLIPTIN; METFORMIN HYDROCHLORIDE | LINAGLIPTIN;METFORMIN HYDROCHLORIDE | TABLET;ORAL | 2.5MG;850MG | No | No |
| 003 | LINAGLIPTIN; METFORMIN HYDROCHLORIDE | LINAGLIPTIN;METFORMIN HYDROCHLORIDE | TABLET;ORAL | 2.5MG;1GM | 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 |
|---|
| 56852 | ORIG | 2018-12-20 |