Application 210169
- Type
- ANDA
- Sponsor
- AIRIS PHARMA PVT LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | VALGANCICLOVIR HYDROCHLORIDE | VALGANCICLOVIR HYDROCHLORIDE | FOR SOLUTION;ORAL | 50MG/ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 71151-003 | VALGANCICLOVIR | valganciclovir | airis PHARMA PVT LTD | ANDA | Current |
| 72205-019 | valganciclovir hydrochloride | valganciclovir hydrochloride | Novadoz Pharmaceuticals LLC | ANDA | Current |