FdaApplication

ANDA 217279

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Identifiers

Properties

PropertyValue
applicant_nameALEMBIC PHARMACEUTICALS LTD
application_typeANDA
approval_date2025-05-22

Products (11)

ProductActive ingredientStrengthDosage form
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMAMLODIPINE BESYLATE; ATORVASTATIN CALCIUMEQ 2.5MG BASE;EQ 40MG BASETABLET;ORAL
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMAMLODIPINE BESYLATE; ATORVASTATIN CALCIUMEQ 2.5MG BASE;EQ 10MG BASETABLET;ORAL
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMAMLODIPINE BESYLATE; ATORVASTATIN CALCIUMEQ 2.5MG BASE;EQ 20MG BASETABLET;ORAL
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMAMLODIPINE BESYLATE; ATORVASTATIN CALCIUMEQ 5MG BASE;EQ 40MG BASETABLET;ORAL
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMAMLODIPINE BESYLATE; ATORVASTATIN CALCIUMEQ 5MG BASE;EQ 20MG BASETABLET;ORAL
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMAMLODIPINE BESYLATE; ATORVASTATIN CALCIUMEQ 5MG BASE;EQ 80MG BASETABLET;ORAL
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMAMLODIPINE BESYLATE; ATORVASTATIN CALCIUMEQ 5MG BASE;EQ 10MG BASETABLET;ORAL
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMAMLODIPINE BESYLATE; ATORVASTATIN CALCIUMEQ 10MG BASE;EQ 10MG BASETABLET;ORAL
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMAMLODIPINE BESYLATE; ATORVASTATIN CALCIUMEQ 10MG BASE;EQ 80MG BASETABLET;ORAL
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMAMLODIPINE BESYLATE; ATORVASTATIN CALCIUMEQ 10MG BASE;EQ 20MG BASETABLET;ORAL
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMAMLODIPINE BESYLATE; ATORVASTATIN CALCIUMEQ 10MG BASE;EQ 40MG BASETABLET;ORAL

11 products