Application 204119
- Type
- NDA
- Sponsor
- HETERO DRUGS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | EFAVIRENZ, LAMIVUDINE, AND TENOFOVIR DISOPROXIL FUMARATE | EFAVIRENZ;LAMIVUDINE;TENOFOVIR DISOPROXIL FUMARATE | TABLET; ORAL | 600MG;300MG;300MG | 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 |
|---|
| 10298 | ORIG | 2012-11-13 |