APPLICATION
ANDA206536
TYPE
ANDA
ORIGINAL APPROVAL
2018-11-20
LATEST ACTION
2024-07-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ATORVASTATIN CALCIUMPrescription
ATORVASTATIN CALCIUM EQ 80MG BASE · TABLET · ORAL
ATORVASTATIN CALCIUMPrescription
ATORVASTATIN CALCIUM EQ 20MG BASE · TABLET · ORAL
ATORVASTATIN CALCIUMPrescription
ATORVASTATIN CALCIUM EQ 40MG BASE · TABLET · ORAL
ATORVASTATIN CALCIUMPrescription
ATORVASTATIN CALCIUM EQ 10MG BASE · TABLET · ORAL
Approval history
2024-07-10Labeling · Supplement 18 · standardAP
2023-05-12Labeling · Supplement 16 · standardAP
2022-02-24Labeling · Supplement 7 · standardAP
2022-02-24Labeling · Supplement 10 · standardAP
2022-02-24Labeling · Supplement 8 · standardAP
2022-02-24Labeling · Supplement 11 · standardAP
2019-10-18Labeling · Supplement 3 · standardAP
2018-11-20UNKNOWN · Original · standardAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.