FDA — authorised 29 April 2016
- Application: ANDA079167
- Marketing authorisation holder: WATSON LABS INC
- Local brand name: ROSUVASTATIN CALCIUM
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Low dose Rosuvastatin in United States
FDA authorised Low dose Rosuvastatin on 29 April 2016 · 5 US adverse-event reports
Marketing authorisations
FDA — authorised 19 July 2016
- Application: ANDA079161
- Marketing authorisation holder: ANVI
- Local brand name: ROSUVASTATIN CALCIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 July 2016
- Application: ANDA079166
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: ROSUVASTATIN CALCIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 July 2016
- Application: ANDA079145
- Marketing authorisation holder: APOTEX
- Local brand name: ROSUVASTATIN CALCIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 July 2016
- Application: ANDA079168
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: ROSUVASTATIN CALCIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 July 2016
- Application: ANDA079169
- Marketing authorisation holder: SUN PHARM
- Local brand name: ROSUVASTATIN CALCIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 October 2016
- Application: ANDA201619
- Marketing authorisation holder: TORRENT
- Local brand name: ROSUVASTATIN CALCIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 October 2016
- Application: ANDA206434
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: ROSUVASTATIN CALCIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 October 2016
- Application: ANDA207408
- Marketing authorisation holder: CHANGZHOU PHARM
- Local brand name: ROSUVASTATIN CALCIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 October 2016
- Application: ANDA207062
- Marketing authorisation holder: RENATA
- Local brand name: ROSUVASTATIN CALCIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 November 2016
- Application: ANDA207453
- Marketing authorisation holder: CADILA PHARMS LTD
- Local brand name: ROSUVASTATIN CALCIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 March 2017
- Application: ANDA206465
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: ROSUVASTATIN CALCIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 July 2017
- Application: ANDA205587
- Marketing authorisation holder: LUPIN
- Local brand name: ROSUVASTATIN CALCIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 November 2017
- Application: ANDA208898
- Marketing authorisation holder: MSN
- Local brand name: ROSUVASTATIN CALCIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 December 2018
- Application: NDA208647
- Marketing authorisation holder: SUN PHARM
- Local brand name: EZALLOR SPRINKLE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 24 April 2019
- Application: ANDA206381
- Marketing authorisation holder: SCIEGEN PHARMS
- Local brand name: ROSUVASTATIN CALCIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 November 2019
- Application: ANDA212059
- Marketing authorisation holder: ZHEJIANG YONGTAI
- Local brand name: ROSUVASTATIN CALCIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 April 2020
- Application: ANDA210667
- Marketing authorisation holder: SUNSHINE
- Local brand name: ROSUVASTATIN CALCIUM
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 5
Most-reported reactions
- Abdominal Distension — 1 report (20%)
- Abdominal Pain — 1 report (20%)
- Diarrhoea — 1 report (20%)
- Fatigue — 1 report (20%)
- Impaired Work Ability — 1 report (20%)
Low dose Rosuvastatin in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Low dose Rosuvastatin approved in United States?
Yes. FDA authorised it on 29 April 2016; FDA authorised it on 19 July 2016; FDA authorised it on 19 July 2016.
Who is the marketing authorisation holder for Low dose Rosuvastatin in United States?
WATSON LABS INC holds the US marketing authorisation.