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FDA ANDA · ANDA217279

AMLODIPINE AND ATORVASTATIN

Sponsor: ALEMBIC

APPLICATION
ANDA217279
TYPE
ANDA
ORIGINAL APPROVAL
2025-05-22
LATEST ACTION
2025-05-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

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 CALCIUMPrescription
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
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 CALCIUMPrescription
AMLODIPINE BESYLATE EQ 2.5MG BASE, ATORVASTATIN CALCIUM EQ 40MG BASE · TABLET · ORAL
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMPrescription
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

Approval history

2025-05-22UNKNOWN · 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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