Orange Book product · Brand (NDA)
NORVIR
RITONAVIR
At a glance
Jun 07, 2017
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 07, 2017
9 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
RITONAVIR
Strength
100MG/PACKET
Dosage form
POWDER
Route
ORAL
TE code
Not listed
Application
NDA 209512
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
- 2010NORVIRBrand (NDA)
NDA 022417 · ABBVIE
- 1999NORVIRBrand (NDA)
NDA 020945 · ABBVIE
- 1996NORVIRBrand (NDA)
NDA 020680 · ABBOTT
- 1996NORVIRBrand (NDA)
NDA 020659 · ABBVIE
- 2024RITONAVIRGeneric (ANDA)
ANDA 205024 · QUAGEN
- 2022RITONAVIRGeneric (ANDA)
ANDA 203759 · CIPLA
- 2020RITONAVIRGeneric (ANDA)
ANDA 205801 · HIKMA
- 2018RITONAVIRGeneric (ANDA)
ANDA 208890 · AMNEAL
- 2018RITONAVIRGeneric (ANDA)
ANDA 206614 · AUROBINDO PHARMA LTD
- 2018RITONAVIRGeneric (ANDA)
ANDA 204587 · HETERO LABS LTD III
- 2015RITONAVIRGeneric (ANDA)
ANDA 202573 · CIPLA
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.
