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`Drugs@FDA: FDA Approved Drug Products
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`Drugs@FDA: FDA Approved Drug
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`New Drug Application (NDA): 021023
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`Company: ALLERGAN
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`Drug Name(s):
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`- RESTASIS (CYCLOSPORINE)
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`PRODUCTS&BODY= HTI'P:IlWWW.ACCESSDATA. FDA.GOVlSCR|PTSlCDE RIDAFII NDEX.CFM ?EVENT=OVERV|EW.PROCESS%26VARAPPLNO=021023
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`Products on NDA 021023
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`A roval Date s and Histor Letters Labels Reviews for NDA 021023
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`v
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`A
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`Original Approvals or Tentative Approvals
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` .9
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`Action
`Date
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`Action
`Submission Type
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`Submission
`Classification
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`10/10/2003 ORIG-1
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`Approval
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`Type 3 - New
`Dosage Form
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`Review
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`Priority;
`Orphan
`Status
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`Letters, Reviews, Labels, Patient Package Inse
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`PRIORITY Review (http:/lwww.accessdata.fda.gov/drugsatfc
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`httpj/www.accessdata.fda.gov/scripts/cder/daf/index.cfm’?event=overview.process&App|No=021023
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`1
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`ALL 2032
`MYLAN PHARMACEUTICALS V. ALLERGAN
`|PR2016-01127
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`1
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`ALL 2032
`MYLAN PHARMACEUTICALS V. ALLERGAN
`IPR2016-01127
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`3/16/2017
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`Drugs@FDA: FDA Approved Drug Products
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