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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077771
Company: HIKMA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET;ORAL Discontinued None No No
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 5MG BASE TABLET;ORAL Discontinued None No No
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 10MG BASE TABLET;ORAL Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/12/2011 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/25/2015 SUPPL-5 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/25/2015 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

11/18/2011 SUPPL-3 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

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