Orange Book product · Generic (ANDA)
ROSUVASTATIN CALCIUM
ROSUVASTATIN CALCIUM
At a glance
Apr 09, 2019
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 09, 2019
7 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
ROSUVASTATIN CALCIUM
Strength
EQ 5MG BASE
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 207626
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of ROSUVASTATIN CALCIUM
- 2018EZALLOR SPRINKLEBrand (NDA)
NDA 208647 · SUN PHARM
- 2003CRESTORBrand (NDA)
NDA 021366 · ASTRAZENECA
- 2025ROSUVASTATIN CALCIUMGeneric (ANDA)
ANDA 206603 · MANKIND PHARMA
- 2024ROSUVASTATIN CALCIUMGeneric (ANDA)
ANDA 207296 · MACLEODS PHARMS LTD
- 2021ROSUVASTATIN CALCIUMGeneric (ANDA)
ANDA 207653 · INVENTIA
- 2020ROSUVASTATIN CALCIUMGeneric (ANDA)
ANDA 210667 · SUNSHINE
- 2019ROSUVASTATIN CALCIUMGeneric (ANDA)
ANDA 212059 · ZHEJIANG YONGTAI
- 2019ROSUVASTATIN CALCIUMGeneric (ANDA)
ANDA 207375 · SHANDONG
- 2019ROSUVASTATIN CALCIUMGeneric (ANDA)
ANDA 206381 · SCIEGEN PHARMS
- 2019ROSUVASTATIN CALCIUMGeneric (ANDA)
ANDA 206513 · ZHEJIANG JINGXIN
- 2018ROSUVASTATIN CALCIUMGeneric (ANDA)
ANDA 208850 · AMNEAL PHARMS CO
- 2017ROSUVASTATIN CALCIUMGeneric (ANDA)
ANDA 208898 · MSN
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.
