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FDA ANDA · ANDA200465

AMLODIPINE AND ATORVASTATIN

Sponsor: MYLAN

APPLICATION
ANDA200465
TYPE
ANDA
ORIGINAL APPROVAL
2013-11-29
LATEST ACTION
2026-06-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription, Discontinued

Products

AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMPrescription
AMLODIPINE BESYLATE EQ 5MG BASE, ATORVASTATIN CALCIUM EQ 20MG BASE · TABLET · ORAL
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMPrescription
AMLODIPINE BESYLATE EQ 10MG BASE, ATORVASTATIN CALCIUM EQ 80MG BASE · TABLET · ORAL
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMDiscontinued
AMLODIPINE BESYLATE EQ 2.5MG BASE, ATORVASTATIN CALCIUM EQ 40MG BASE · TABLET · ORAL
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMDiscontinued
AMLODIPINE BESYLATE EQ 2.5MG BASE, ATORVASTATIN CALCIUM EQ 10MG BASE · TABLET · ORAL
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMPrescription
AMLODIPINE BESYLATE EQ 10MG BASE, ATORVASTATIN CALCIUM EQ 10MG BASE · TABLET · ORAL
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMPrescription
AMLODIPINE BESYLATE EQ 5MG BASE, ATORVASTATIN CALCIUM EQ 40MG BASE · TABLET · ORAL
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMPrescription
AMLODIPINE BESYLATE EQ 5MG BASE, ATORVASTATIN CALCIUM EQ 10MG BASE · TABLET · ORAL
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMPrescription
AMLODIPINE BESYLATE EQ 10MG BASE, ATORVASTATIN CALCIUM EQ 40MG BASE · TABLET · ORAL
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMDiscontinued
AMLODIPINE BESYLATE EQ 2.5MG BASE, ATORVASTATIN CALCIUM EQ 20MG BASE · TABLET · ORAL
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMPrescription
AMLODIPINE BESYLATE EQ 10MG BASE, ATORVASTATIN CALCIUM EQ 20MG BASE · TABLET · ORAL
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMPrescription
AMLODIPINE BESYLATE EQ 5MG BASE, ATORVASTATIN CALCIUM EQ 80MG BASE · TABLET · ORAL

Approval history

2026-06-25Labeling · Supplement 10 · standardAP
2022-10-06Labeling · Supplement 8 · standardAP
2019-11-06Labeling · Supplement 6 · standardAP
2015-11-16Labeling · Supplement 2 · standardAP
2013-11-29Not Applicable · Original — Letter ↗AP
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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