Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022134
Company: ALLERGAN

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LASTACAFT ALCAFTADINE 0.25% SOLUTION/DROPS;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
07/28/2010 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022134s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022134s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022134s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022134s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/30/2015 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022134s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022134Orig1s004ltr.pdf
07/25/2014 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.
08/12/2014 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.
12/04/2014 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022134s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022134Orig1s001ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
09/30/2015 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022134s004lbl.pdf
12/04/2014 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022134s001lbl.pdf
07/28/2010 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022134s000lbl.pdf

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