Orange Book product · Brand (NDA)
KALETRA
LOPINAVIR; RITONAVIR
At a glance
Sep 15, 2000
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 15, 2000
26 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
LOPINAVIR; RITONAVIR
Strength
133.3MG;33.3MG
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 021226
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active ingredient are listed below.
- 2007KALETRABrand (NDA)
NDA 021906 · 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.
