Orange Book product · Generic (ANDA)
DARUNAVIR
DARUNAVIR
At a glance
Nov 21, 2017
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 21, 2017
8 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
DARUNAVIR
Strength
600MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
ANDA 202118
Product number
001
Marketing status
DISCN
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
- 2023DARUNAVIRGeneric (ANDA)
ANDA 202083 · HETERO LABS LTD III
- 2022DARUNAVIRGeneric (ANDA)
ANDA 202073 · LUPIN
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.
