Application 214036
- Type
- ANDA
- Sponsor
- INTAS PHARMS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TRIFLURIDINE; TIPIRACIL | TRIFLURIDINE; TIPIRACIL | TABLET;ORAL | 15MG/6.14MG | No | No |
| 002 | TRIFLURIDINE; TIPIRACIL | TRIFLURIDINE; TIPIRACIL | TABLET;ORAL | 20MG/8.19MG | 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 |
|---|
| 72943 | ORIG | 2022-12-20 |