Application 213306
- Type
- ANDA
- Sponsor
- GRANULES PHARMS
Application Products#
| 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 | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 70010-051 | VALGANCICLOVIR HYDROCHLORIDE | VALGANCICLOVIR | Granules Pharmaceuticals Inc. | ANDA | Current |
| 70010-051 | VALGANCICLOVIR HYDROCHLORIDE | VALGANCICLOVIR | Granules Pharmaceuticals Inc. | ANDA | Current |
| 70010-051 | VALGANCICLOVIR HYDROCHLORIDE | VALGANCICLOVIR | Granules Pharmaceuticals Inc. | ANDA | Current |
| 70069-810 | VALGANCICLOVIR HYDROCHLORIDE | VALGANCICLOVIR | Somerset Therapeutics, LLC | ANDA | Current |