Application 078674
- Type
- ANDA
- Sponsor
- SANDOZ
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ROSIGLITAZONE MALEATE | ROSIGLITAZONE MALEATE | TABLET; ORAL | 2MG | No | No |
| 002 | ROSIGLITAZONE MALEATE | ROSIGLITAZONE MALEATE | TABLET; ORAL | 4MG | No | No |
| 003 | ROSIGLITAZONE MALEATE | ROSIGLITAZONE MALEATE | TABLET; ORAL | 8MG | 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 |
|---|
| 44391 | ORIG | 2009-11-12 |