Orange Book product · Generic (ANDA)
VALGANCICLOVIR HYDROCHLORIDE
VALGANCICLOVIR HYDROCHLORIDE
At a glance
Feb 17, 2022
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 17, 2022
4 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
VALGANCICLOVIR HYDROCHLORIDE
Strength
50MG/ML
Dosage form
FOR SOLUTION
Route
ORAL
TE code
AB
Application
ANDA 210169
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of VALGANCICLOVIR HYDROCHLORIDE
- 2009VALCYTEBrand (NDA)
NDA 022257 · CHEPLAPHARM
- 2001VALCYTEBrand (NDA)
NDA 021304 · 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
- 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.
