Orange Book product · Brand (NDA)
DIOVAN
VALSARTAN
At a glance
Aug 14, 2002
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 14, 2002
24 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
VALSARTAN
Strength
40MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 021283
Product number
004
Marketing status
RX
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.
- 2017PREXXARTANBrand (NDA)
NDA 209139 · CARMEL BIOSCIENCES
- 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.
