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FDA ANDA · ANDA077575

ATORVASTATIN CALCIUM

Sponsor: CHARTWELL RX

APPLICATION
ANDA077575
TYPE
ANDA
ORIGINAL APPROVAL
2012-05-29
LATEST ACTION
2024-07-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ATORVASTATIN CALCIUMPrescription
ATORVASTATIN CALCIUM EQ 40MG BASE · TABLET · ORAL
ATORVASTATIN CALCIUMPrescription
ATORVASTATIN CALCIUM EQ 10MG BASE · TABLET · ORAL
ATORVASTATIN CALCIUMPrescription
ATORVASTATIN CALCIUM EQ 80MG BASE · TABLET · ORAL
ATORVASTATIN CALCIUMPrescription
ATORVASTATIN CALCIUM EQ 20MG BASE · TABLET · ORAL

Approval history

2024-07-15Labeling · Supplement 16 · standardAP
2023-03-30Labeling · Supplement 15 · standardAP
2021-03-08Labeling · Supplement 13 · standardAP
2021-03-08Labeling · Supplement 14 · standardAP
2021-03-08Labeling · Supplement 12 · standardAP
2019-11-04Labeling · Supplement 11 · standardAP
2019-11-04Labeling · Supplement 9 · standardAP
2018-12-07Labeling · Supplement 10 · standardAP
2015-10-06Labeling · Supplement 4 · standardAP
2014-09-23Labeling · Supplement 3 · standardAP
2012-12-12Labeling · Supplement 2 · standardAP
2012-05-29Original — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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