Application 200790
- Type
- ANDA
- Sponsor
- ENDO PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VALGANCICLOVIR HYDROCHLORIDE | VALGANCICLOVIR HYDROCHLORIDE | TABLET;ORAL | EQ 450MG BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0603-6330 | Valganciclovir | Valganciclovir hydrochloride | Par Pharmaceutical | ANDA | Current |
| 42291-875 | Valganciclovir | Valganciclovir hydrochloride | AvKARE, Inc. | ANDA | Current |
| 42291-875 | Valganciclovir | Valganciclovir hydrochloride | AvKARE | ANDA | Current |
| 63629-2288 | Valganciclovir | Valganciclovir hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2288 | Valganciclovir | Valganciclovir hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 64380-153 | Valganciclovir | Valganciclovir hydrochloride | Strides Pharma Science Limited | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 32057 | ORIG | 2014-11-10 |