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`Drugs@FDA: FDA Approved Drug Products
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`Drugs@FDA: FDA Approved Drug
`Products
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`New Drug Application (NDA): 050790
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`Company: ALLERGAN
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`Drug Name(s):
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`- RESTASIS (CYCLOSPORINE)
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`- RESTASIS MULTIDOSE (CYCLOSPORINE)
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`R EMAIL §MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG
`PRODUCTS&BODY=H'|'|'P:IIWWW.ACCESSDATA.FDA.GOVISCR|PTSICDERlDAFI|NDEX.CFM?EVENT=OVERVlEW.PROCESS%26VARAPPLNO=050790
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`Products on NDA 050790
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`A roval Date s and Histor Letters Labels Reviews for NDA 050790
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`Original Approvals or Tentative Approvals
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`Action
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`Submission
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`Review
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`Priority;
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`Orphan
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`Letters, Reviews, Labels, Patient Package Inse
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`Drugs@FDA: FDA Approved Drug Products
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`12/23/2002 ORIG-1
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`Approval
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`Type 3 - New
`Dosage Form
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`PRIORITY Label (PDF) (http://www.accessdata.fda.govldrug
`Letter (PDF) (http:llwww.accessdata.fda.govldrug
`Review (http:lIwww.accessdata.fda.govldrugsatfc
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`Supplements
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`CSVExcelPrint
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`Action
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`Date
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`Submission
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`Submission
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`Classification
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`Letters, Reviews, Labels,
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`Patient Package Insert
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`10/27/2016
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`SUPPL-25
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`LABELING
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`Label (PDF)
`(http://www.accessdata.fda.govIdrugsatfda_docsllabel/2016/050790502
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`10/27/2016
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`SUPPL-24
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`MANUF (CMC)
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`Label (PDF)
`(http:lIwww.accessdata.fda.gov/drugsatfda_docsllabelI2016/050790s02
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`01/16/2014
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`SUPPL-22
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`12/05/2013
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`SUPPL-23
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`05/31/2013
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`SUPPL-21
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`Manufacturing
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`Manufacturing
`(CMC)
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`Manufacturing
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`Label (PDF)
`(http:/lwww.accessdata.fda.gov/drugsatfda_docsllabell2013/050790502
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`01/16/2013
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`SUPPL-19
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`12/03/2012
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`SUPPL-20
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`Manufacturing
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`Labeling-
`Package Insert
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`12/27/2007
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`SUPPL-13
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`Labeling-
`Container/Carton
`Labels
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`10/01/2003
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`SUPPL-4
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`Labeling
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`Label (PDF)
`(http:lIwww.accessdata.fda.gov/drugsatfda_docsl|abe|/2012/050790502
`Letter (PDF)
`(http:lIwww.accessdata.fda.gov/drugsatfda_docsIappletterI2012I05079I
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`Letter (PDF)
`(http:lIwww.accessdata.fda.gov/drugsatfda_docsIappletterI2003/50790:
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`10/01/2003
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`SUPPL-3
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`Manufacturing
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`Packaging
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`Letter (PDF)
`(http:/Iwww.accessdata.fda.gov/drugsatfda_docslapp|etter/2003I50790:
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`Action
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`Date
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`Submission
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`Letters, Reviews, Labels,
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`Submission Classification
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`Patient Package Insert
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`09/16/2003
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`SUPPL-1
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`Labeling
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`Label (PDF)
`(http:/lwww.accessdata.fda.govIdrugsatfda_docs/labell2003l50790slrot
`Letter (PDF)
`(http:l/www.accessdata.fda.govIdrugsatfda_docslappletterI2003/50790:
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`09/12/2003
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`SUPPL-2
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`Manufacturing
`(CMC)
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`Review
`(http:lIwww.accessdata.fda.gov/drugsatfda_docsIndal2003I050790_S0!
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`Labels for NDA 050790
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