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FDA ANDA · ANDA204991

ATORVASTATIN CALCIUM

Sponsor: LUPIN

APPLICATION
ANDA204991
TYPE
ANDA
ORIGINAL APPROVAL
2019-03-06
LATEST ACTION
2023-06-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

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

Approval history

2023-06-09Labeling · Supplement 14 · standardAP
2021-05-04Labeling · Supplement 6 · standardAP
2021-05-04Labeling · Supplement 4 · standardAP
2021-05-04Labeling · Supplement 7 · standardAP
2019-10-16Labeling · Supplement 2 · standardAP
2019-03-06UNKNOWN · Original · standardAP
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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