Application 215319
- Type
- NDA
- Sponsor
- LAURUS GENERICS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | DOLUTEGRAVIR | DOLUTEGRAVIR | FILM;ORAL | 5MG | No | No |
| 002 | DOLUTEGRAVIR | DOLUTEGRAVIR | FILM;ORAL | 10MG | 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 |
|---|
| 74128 | ORIG | 2023-05-01 |