← FDA DRUG APPROVALS

FDA ANDA · ANDA203874

AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM

Sponsor: DR REDDYS

APPLICATION
ANDA203874
TYPE
ANDA
ORIGINAL APPROVAL
2014-03-07
LATEST ACTION
2023-05-31
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

2023-05-31Labeling · Supplement 6 · standardAP
2023-05-31Labeling · Supplement 4 · standardAP
2023-05-31Labeling · Supplement 15 · standardAP
2023-05-31Labeling · Supplement 7 · standardAP
2023-05-31Labeling · Supplement 5 · standardAP
2023-05-31Labeling · Supplement 16 · standardAP
2023-05-31Labeling · Supplement 3 · standardAP
2023-05-31Labeling · Supplement 12 · standardAP
2015-11-17Labeling · Supplement 2 · standardAP
2015-11-17Labeling · Supplement 1 · standardAP
2014-03-07UNKNOWN · OriginalAP
VIEW ON DRUGS@FDA ↗

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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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