`
`Drugs@FDA: FDA Approved Drug
`Products
`
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`New Drug Application (NDA): 050790
`Company: ALLERGAN
`
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`
`Products on NDA 050790
`
`CSVExcelPrint
`Drug
`Active
`Name
`Ingredients
`
`(cid:140)
`
`Strength Dosage Form/Route
`
`Marketing
`Status
`
`RLD
`
`TE
`Code
`
`RESTASIS
`MULTIDOSE
`
`CYCLOSPORINE
`
`0.05%
`
`EMULSION;OPHTHALMIC
`
`Prescription
`
`Yes
`
`None
`
`CYCLOSPORINE
`RESTASIS
`Showing 1 to 2 of 2 entries
`
`0.05%
`
`EMULSION;OPHTHALMIC
`
`Prescription
`
`Yes
`
`None
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 050790
`
`(cid:139)
`
`Original Approvals or Tentative Approvals
`CSVExcelPrint
`
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=050790
`
`MYLAN - EXHIBIT 1064
`Mylan Pharmaceuticals Inc. et al. v. Allergan, Inc.
`IPR2016-01127, -01128, -01129, -01130, -01131, & -01132
`
`
`
`Action
`Date
`
`Submission
`
`Action
`Type
`
`Submission
`Classification
`
`12/23/2002 ORIG-1
`
`Approval Type 3 - New
`Dosage Form
`
`Page 2 of 3
`
`Letters, Re
`
`Review
`Priority;
`Orphan
`Status
`
`PRIORITY Label (PDF) (https://www.acces
`Letter (PDF) (https://www.acce
`Review (https://www.accessda
`
`Showing 1 to 1 of 1 entries
`
`Supplements
`CSVExcelPrint
`Action
`Date
`
`Submission
`
`Submission
`Classification
`
`Letters, Reviews, L
`Patient Package In
`
`10/27/2016
`
`SUPPL-25
`
`Labeling-
`Package Insert
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/lab
`
`10/27/2016
`
`SUPPL-24
`
`Manufacturing
`(CMC)
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/lab
`
`01/16/2014
`
`SUPPL-22
`
`Manufacturing
`(CMC)
`
`12/05/2013
`
`SUPPL-23
`
`Manufacturing
`(CMC)
`
`05/31/2013
`
`SUPPL-21
`
`01/16/2013
`
`SUPPL-19
`
`Manufacturing
`(CMC)
`
`Manufacturing
`(CMC)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatf
`
`12/03/2012
`
`SUPPL-20
`
`Labeling-
`Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatf
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/app
`
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=050790
`
`
`
`Action
`Date
`
`Submission
`
`12/27/2007
`
`SUPPL-13
`
`Submission
`Classification
`
`Labeling-
`Container/Carton
`Labels
`
`Page 3 of 3
`
`Letters, Reviews, L
`Patient Package In
`
`10/01/2003
`
`SUPPL-4
`
`Labeling
`
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/app
`
`10/01/2003
`
`SUPPL-3
`
`Manufacturing
`(CMC)
`-Packaging
`
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/app
`
`09/16/2003
`
`SUPPL-1
`
`Labeling
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/lab
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/app
`
`09/12/2003
`
`SUPPL-2
`
`Manufacturing
`(CMC)
`
`Review
`(https://www.accessdata.fda.gov/drugsatfda_docs/nda
`
`Showing 1 to 12 of 12 entries
`
`Labels for NDA 050790
`
`(cid:140)
`
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=050790
`
`