Orange Book product · Brand (NDA)
PREXXARTAN
VALSARTAN
At a glance
Dec 19, 2017
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 19, 2017
8 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
VALSARTAN
Strength
4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
SOLUTION
Route
ORAL
TE code
Not listed
Application
NDA 209139
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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.
- 2002DIOVANBrand (NDA)
NDA 021283 · NOVARTIS
- 1996DIOVANBrand (NDA)
NDA 020665 · NOVARTIS
- 2026VALSARTANGeneric (ANDA)
ANDA 218897 · LAURUS
- 2025VALSARTANGeneric (ANDA)
ANDA 216460 · RUBICON RESEARCH
- 2024VALSARTANGeneric (ANDA)
ANDA 218169 · RENATA
- 2024VALSARTANGeneric (ANDA)
ANDA 218991 · ZYDUS LIFESCIENCES
- 2021VALSARTANGeneric (ANDA)
ANDA 214102 · NOVITIUM PHARMA
- 2021VALSARTANGeneric (ANDA)
ANDA 204038 · SCIEGEN PHARMS
- 2021VALSARTANGeneric (ANDA)
ANDA 201618 · DR REDDYS
- 2019VALSARTANGeneric (ANDA)
ANDA 205536 · ALKEM LABS LTD
- 2018VALSARTANGeneric (ANDA)
ANDA 209261 · UNICHEM
- 2018VALSARTANGeneric (ANDA)
ANDA 205347 · SQUARE PHARMS PLC
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.
