Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022221
Company: AKORN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AKTEN LIDOCAINE HYDROCHLORIDE 3.5% GEL;OPHTHALMIC Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/07/2008 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022221lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022221s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022221_akten_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022221s000_SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/11/2014 SUPPL-5 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022221s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022221Orig1s005ltr.pdf
12/07/2012 SUPPL-2 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022221s002lbl.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/11/2014 SUPPL-5 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022221s005lbl.pdf
12/07/2012 SUPPL-2 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022221s002lbl.pdf
10/07/2008 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022221lbl.pdf

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