Orange Book product · Generic (ANDA)
VALACYCLOVIR HYDROCHLORIDE
VALACYCLOVIR HYDROCHLORIDE
At a glance
Mar 18, 2020
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 18, 2020
6 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
VALACYCLOVIR HYDROCHLORIDE
Strength
EQ 1GM BASE
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 209553
Product number
002
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of VALACYCLOVIR HYDROCHLORIDE
- 1995VALTREXBrand (NDA)
NDA 020487 · GLAXOSMITHKLINE
- 2017VALACYCLOVIR HYDROCHLORIDEGeneric (ANDA)
ANDA 079137 · ZYDUS LIFESCIENCES
- 2015VALACYCLOVIR HYDROCHLORIDEGeneric (ANDA)
ANDA 203047 · HETERO LABS LTD V
- 2014VALACYCLOVIR HYDROCHLORIDEGeneric (ANDA)
ANDA 090500 · APOTEX
- 2012VALACYCLOVIR HYDROCHLORIDEGeneric (ANDA)
ANDA 201506 · JUBILANT GENERICS
- 2011VALACYCLOVIR HYDROCHLORIDEGeneric (ANDA)
ANDA 090370 · WATSON LABS INC
- 2010VALACYCLOVIR HYDROCHLORIDEGeneric (ANDA)
ANDA 077478 · AIPING PHARM INC
- 2010VALACYCLOVIR HYDROCHLORIDEGeneric (ANDA)
ANDA 090682 · AUROBINDO PHARMA
- 2010VALACYCLOVIR HYDROCHLORIDEGeneric (ANDA)
ANDA 090216 · CHARTWELL RX
- 2010VALACYCLOVIR HYDROCHLORIDEGeneric (ANDA)
ANDA 077135 · CIPLA
- 2010VALACYCLOVIR HYDROCHLORIDEGeneric (ANDA)
ANDA 078656 · HIKMA
- 2010VALACYCLOVIR HYDROCHLORIDEGeneric (ANDA)
ANDA 078518 · MYLAN PHARMS INC
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.

