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FDA ANDA · ANDA207062

ROSUVASTATIN CALCIUM

Sponsor: RENATA

APPLICATION
ANDA207062
TYPE
ANDA
ORIGINAL APPROVAL
2016-10-31
LATEST ACTION
2020-03-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ROSUVASTATIN CALCIUMPrescription
ROSUVASTATIN CALCIUM EQ 40MG BASE · TABLET · ORAL
ROSUVASTATIN CALCIUMPrescription
ROSUVASTATIN CALCIUM EQ 10MG BASE · TABLET · ORAL
ROSUVASTATIN CALCIUMPrescription
ROSUVASTATIN CALCIUM EQ 20MG BASE · TABLET · ORAL
ROSUVASTATIN CALCIUMPrescription
ROSUVASTATIN CALCIUM EQ 5MG BASE · TABLET · ORAL

Approval history

2020-03-09Labeling · Supplement 1 · standardAP
2020-03-09Labeling · Supplement 6 · standardAP
2016-10-31UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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