Application 217070
- Type
- NDA
- Sponsor
- AUROBINDO PHARMA USA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ABACAVIR; DOLUTEGRAVIR; LAMIVUDINE | ABACAVIR; DOLUTEGRAVIR; LAMIVUDINE | TABLET; ORAL | 60MG;5MG;30MG | 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 |
|---|
| 75078 | ORIG | 2023-08-15 |