Application 212890
- Type
- ANDA
- Sponsor
- AJANTA PHARMA LTD
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 |
|---|---|---|---|---|---|
| 27241-159 | Valganciclovir hydrochloride | Valganciclovir hydrochloride | Ajanta Pharma Limited | ANDA | Current |
| 27241-159 | Valganciclovir hydrochloride | Valganciclovir hydrochloride | Ajanta Pharma Limited | ANDA | Current |
| 27241-159 | Valganciclovir hydrochloride | Valganciclovir hydrochloride | Ajanta Pharma USA Inc. | ANDA | Current |
| 27241-159 | Valganciclovir hydrochloride | Valganciclovir hydrochloride | Ajanta Pharma USA Inc. | ANDA | Current |
| 27241-159 | Valganciclovir hydrochloride | Valganciclovir hydrochloride | Ajanta Pharma Limited | ANDA | Current |