Orange Book product · Brand (NDA)
LIVALO
PITAVASTATIN CALCIUM
At a glance
Aug 03, 2009
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 03, 2009
17 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
PITAVASTATIN CALCIUM
Strength
EQ 1MG BASE
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 022363
Product number
001
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.
- 2024PITAVASTATIN CALCIUMGeneric (ANDA)
ANDA 205961 · AMNEAL PHARMS NY
- 2024PITAVASTATIN CALCIUMGeneric (ANDA)
ANDA 205977 · HETERO LABS LTD V
- 2023PITAVASTATIN CALCIUMGeneric (ANDA)
ANDA 206029 · LUPIN
- 2023PITAVASTATIN CALCIUMGeneric (ANDA)
ANDA 206047 · ZYDUS PHARMS
- 2019PITAVASTATIN CALCIUMGeneric (ANDA)
ANDA 206070 · MYLAN
- 2017PITAVASTATIN CALCIUMGeneric (ANDA)
ANDA 205932 · ORIENT PHARMA CO LTD
- 2017PITAVASTATIN CALCIUMGeneric (ANDA)
ANDA 205955 · SAWAI USA
- 2016PITAVASTATIN CALCIUMGeneric (ANDA)
ANDA 206015 · AUROBINDO PHARMA
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.
