Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022026
Company: SYNTHON PHARMS

• Summary Review

Products on NDA 022026

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	Yes	No
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING;ORAL	Discontinued	None	Yes	No
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022026

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

Labels for NDA 022026

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