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FDA ANDA · ANDA091226

ATORVASTATIN CALCIUM

Sponsor: MYLAN PHARMS INC

APPLICATION
ANDA091226
TYPE
ANDA
ORIGINAL APPROVAL
2012-05-29
LATEST ACTION
2024-12-05
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

2024-12-05Labeling · Supplement 32 · standardAP
2023-07-11Labeling · Supplement 30 · standardAP
2021-01-15Labeling · Supplement 18 · standardAP
2021-01-15Labeling · Supplement 16 · standardAP
2021-01-15Manufacturing (CMC) · Supplement 10 · unknownAP
2021-01-15Labeling · Supplement 19 · standardAP
2021-01-15Labeling · Supplement 13 · standardAP
2015-11-09Labeling · Supplement 8 · standardAP
2014-10-26Labeling · Supplement 6 · standardAP
2014-09-23Labeling · Supplement 2 · standardAP
2013-04-05Labeling · Supplement 1 · standard — Review ↗AP
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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