Orange Book product · Brand (NDA)
KALETRA
LOPINAVIR; RITONAVIR
At a glance
Nov 09, 2007
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 09, 2007
18 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
LOPINAVIR; RITONAVIR
Strength
100MG;25MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 021906
Product number
002
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.
- 2000KALETRABrand (NDA)
NDA 021226 · ABBVIE
- 2000KALETRABrand (NDA)
NDA 021251 · ABBVIE
- 2025LOPINAVIR AND RITONAVIRGeneric (ANDA)
ANDA 214696 · MICRO LABS
- 2024LOPINAVIR AND RITONAVIRGeneric (ANDA)
ANDA 204739 · MACLEODS PHARMS LTD
- 2024LOPINAVIR AND RITONAVIRGeneric (ANDA)
ANDA 079074 · MYLAN LABS LTD
- 2022LOPINAVIR AND RITONAVIRGeneric (ANDA)
ANDA 213857 · LAURUS
- 2021LOPINAVIR AND RITONAVIRGeneric (ANDA)
ANDA 091677 · HETERO LABS LTD III
- 2016LOPINAVIR AND RITONAVIRGeneric (ANDA)
ANDA 207407 · LANNETT CO INC
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.
