Orange Book product · Brand (NDA)
CRESTOR
ROSUVASTATIN CALCIUM
At a glance
Aug 12, 2003
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 12, 2003
23 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
ROSUVASTATIN CALCIUM
Strength
EQ 5MG BASE
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 021366
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.
- 2018EZALLOR SPRINKLEBrand (NDA)
NDA 208647 · SUN PHARM
- 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 207626 · UMEDICA
- 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.
