Orange Book product · Brand (NDA)
VALCYTE
VALGANCICLOVIR HYDROCHLORIDE
At a glance
Mar 29, 2001
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 29, 2001
25 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
VALGANCICLOVIR HYDROCHLORIDE
Strength
EQ 450MG BASE
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 021304
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2009VALCYTEBrand (NDA)
NDA 022257 · CHEPLAPHARM
- 2026VALGANCICLOVIR HYDROCHLORIDEGeneric (ANDA)
ANDA 218838 · MICRO LABS
- 2025VALGANCICLOVIR HYDROCHLORIDEGeneric (ANDA)
ANDA 218027 · SPH ZHONGXI PHARM
- 2024VALGANCICLOVIR HYDROCHLORIDEGeneric (ANDA)
ANDA 212876 · SOMERSET THERAPS LLC
- 2023VALGANCICLOVIR HYDROCHLORIDEGeneric (ANDA)
ANDA 216317 · APPCO
- 2022VALGANCICLOVIR HYDROCHLORIDEGeneric (ANDA)
ANDA 215124 · AUROBINDO PHARMA
- 2022VALGANCICLOVIR HYDROCHLORIDEGeneric (ANDA)
ANDA 211475 · HETERO LABS LTD V
- 2022VALGANCICLOVIR HYDROCHLORIDEGeneric (ANDA)
ANDA 210169 · MSN
- 2021VALGANCICLOVIR HYDROCHLORIDEGeneric (ANDA)
ANDA 205151 · PHARMOBEDIENT
- 2020VALGANCICLOVIR HYDROCHLORIDEGeneric (ANDA)
ANDA 213306 · GRANULES
- 2020VALGANCICLOVIR HYDROCHLORIDEGeneric (ANDA)
ANDA 212890 · AJANTA PHARMA LTD
- 2019VALGANCICLOVIR HYDROCHLORIDEGeneric (ANDA)
ANDA 212234 · AJANTA PHARMA LTD
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
