Orange Book product · Generic (ANDA)
PITAVASTATIN CALCIUM
PITAVASTATIN CALCIUM
At a glance
Apr 30, 2024
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 30, 2024
2 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
PITAVASTATIN CALCIUM
Strength
EQ 1MG BASE
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 205977
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of PITAVASTATIN CALCIUM
- 2009LIVALOBrand (NDA)
NDA 022363 · KOWA CO
- 2024PITAVASTATIN CALCIUMGeneric (ANDA)
ANDA 205961 · AMNEAL PHARMS NY
- 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.
