Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022026
Company: SYNTHON PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET, ORALLY DISINTEGRATING;ORAL Discontinued None No No
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 5MG BASE TABLET, ORALLY DISINTEGRATING;ORAL Discontinued None No No
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 10MG BASE TABLET, ORALLY DISINTEGRATING;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
09/27/2007 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022026s000ltr2.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022026_amlodipine_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022026s000_SumR.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/27/2007 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022026lbl.pdf

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