Application 091593
- Type
- ANDA
- Sponsor
- CIPLA LIMITED
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | TABLET; ORAL | 600MG | No | No |
| 002 | EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | TABLET; ORAL | 200MG | No | No |
| 003 | EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | TABLET; ORAL | 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 |
|---|
| 31542 | ORIG | 2012-02-29 |