Orange Book product · Generic (ANDA)
DARUNAVIR
DARUNAVIR
At a glance
Sep 14, 2023
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 14, 2023
2 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
DARUNAVIR
Strength
400MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 202083
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of DARUNAVIR
- 2011PREZISTABrand (NDA)
NDA 202895 · JANSSEN PRODS
- 2008PREZISTABrand (NDA)
NDA 021976 · JANSSEN PRODS
- 2025DARUNAVIRGeneric (ANDA)
ANDA 202136 · MYLAN
- 2025DARUNAVIRGeneric (ANDA)
ANDA 216168 · ANNORA PHARMA
- 2023DARUNAVIRGeneric (ANDA)
ANDA 214085 · ZYDUS LIFESCIENCES
- 2023DARUNAVIRGeneric (ANDA)
ANDA 212493 · AMNEAL
- 2023DARUNAVIRGeneric (ANDA)
ANDA 210677 · AUROBINDO PHARMA LTD
- 2023DARUNAVIRGeneric (ANDA)
ANDA 206288 · CIPLA
- 2023DARUNAVIRGeneric (ANDA)
ANDA 211578 · DR REDDYS
- 2023DARUNAVIRGeneric (ANDA)
ANDA 215389 · MSN
- 2022DARUNAVIRGeneric (ANDA)
ANDA 202073 · LUPIN
- 2017DARUNAVIRGeneric (ANDA)
ANDA 202118 · TEVA PHARMS USA
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.
