Application 214263
- Type
- ANDA
- Sponsor
- ZYDUS PHARMS USA INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | OSIMERTINIB MESYLATE | OSIMERTINIB MESYLATE | TABLET;ORAL | 40MG | No | No |
| 002 | OSIMERTINIB MESYLATE | OSIMERTINIB MESYLATE | TABLET;ORAL | 80MG | 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 |
|---|
| 68031 | ORIG | 2021-07-08 |