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`New Drug Application (NDA): 020490
`Company: ALLERGAN
`
` EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG
`PRODUCTS&BODY=HTTP://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?
`EVENT=OVERVIEW.PROCESS%26VARAPPLNO=020490)
`
`Products on NDA 020490
`
`CSV
`
`Excel
`
`
`Drug
`Name
`
`Active
`Ingredients
`
`ALPHAGAN
`
`BRIMONIDINE
`TARTRATE
`
`Showing 1 to 1 of 1 entries
`
`
`
`Strength
`
`Dosage Form/Route
`
`Marketing
`Status
`
`TE
`Code
`
`RLD
`
`0.5%
`
`SOLUTION/DROPS;OPHTHALMIC
`
`Discontinued
`
`None
`
`No
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 020490
`
`
`
`Original Approvals or Tentative Approvals
`
`
`
`CSV
`
`Excel
`
`
`Action
`Date
`
`Submission
`
`Action
`Type
`
`Submission
`Classification
`
`03/13/1997
`
`ORIG-1
`
`Approval
`
`Type 3 - New
`Dosage Form
`
`Letters,
`Reviews,
`Labels,
`Patient
`Package
`Insert
`
`Review
`Priority;
`Orphan
`Status
`
`STANDARD
`
`Notes
`
`Label is
`not
`available
`on this
`site.
`
`Showing 1 to 1 of 1 entries
`
`Supplements
`
`CSV
`
`Excel
`
`
`Action
`Date
`
`Submission
`
`03/23/2016
`
`SUPPL-8
`
`12/20/2001
`
`SUPPL-7
`
`04/09/2001
`
`SUPPL-6
`
`Supplement
`Categories
`or Approval
`Type
`
`Labeling-
`Package Insert
`
`Efficacy-New
`Patient
`Population
`
`Manufacturing
`(CMC)-Control
`
`05/26/2000
`
`SUPPL-5
`
`Manufacturing
`(CMC)-Control
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/0204
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/lab
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nd
`490S007_Brimonidine%20Tartrate%20Ophthalmic_Approv.pdf)
`Review (https://www.accessdata.fda.gov/drugsatfda_docs/nda/20
`490s007_Alphagan.cfm)
`
`
`
`Action
`Date
`
`Submission
`
`08/26/1999
`
`SUPPL-4
`
`Supplement
`Categories
`or Approval
`Type
`
`Manufacturing
`(CMC)-Control
`
`05/20/1998
`
`SUPPL-3
`
`Manufacturing
`(CMC)
`
`02/25/1998
`
`SUPPL-2
`
`Manufacturing
`(CMC)-Control
`
`01/15/1998
`
`SUPPL-1
`
`Manufacturing
`(CMC)-Control
`
`Showing 1 to 8 of 8 entries
`
`Labels for NDA 020490
`
`Letters, Reviews, Labels, Patient Package Insert
`
`
`
`