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FDA ANDA · ANDA209912

ATORVASTATIN CALCIUM

atorvastatin calcium, film coated

Sponsor: GRAVITI PHARMS

APPLICATION
ANDA209912
TYPE
ANDA
ORIGINAL APPROVAL
2018-06-18
LATEST ACTION
2024-06-14
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

2024-06-14Labeling · Supplement 27 · standardAP
2023-07-10Labeling · Supplement 23 · standardAP
2021-11-30Labeling · Supplement 18 · standardAP
2021-11-30Labeling · Supplement 10 · standardAP
2021-11-30Labeling · Supplement 17 · standardAP
2019-08-07Labeling · Supplement 6 · standardAP
2019-08-07Labeling · Supplement 2 · standardAP
2018-06-18UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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