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FDA ANDA · ANDA207762

AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM

Sponsor: APDM PHARMS

APPLICATION
ANDA207762
TYPE
ANDA
ORIGINAL APPROVAL
2019-01-11
LATEST ACTION
2023-09-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

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 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

Approval history

2023-09-18Labeling · Supplement 6 · standardAP
2023-09-18Labeling · Supplement 4 · standardAP
2023-09-18Labeling · Supplement 2 · standardAP
2023-09-18Labeling · Supplement 1 · standardAP
2019-01-11UNKNOWN · Original · standardAP
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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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