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`New Drug Application (NDA): 021262
`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=021262)
`
`Products on NDA 021262
`
`CSV
`
`Excel
`
`
`Drug
`Name
`
`Active
`Ingredients
`
`ALPHAGAN
`P
`
`BRIMONIDINE
`TARTRATE
`
`Showing 1 to 1 of 1 entries
`
`
`
`Strength
`
`Dosage Form/Route
`
`Marketing
`Status
`
`TE
`Code
`
`RLD
`
`0.15%
`
`SOLUTION/DROPS;OPHTHALMIC
`
`Prescription
`
`AT
`
`Yes
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 021262
`
`
`
`Original Approvals or Tentative Approvals
`
`
`
`CSV
`
`Excel
`
`
`Action
`Date
`
`Submission
`
`Action
`Type
`
`Submission
`Classification
`
`03/16/2001
`
`ORIG-1
`
`Approval
`
`Type 3 - New
`Dosage Form
`
`Review
`Priority;
`Orphan
`Status
`
`STANDARD
`
`Letters, Reviews, Labels, Patie
`
`Label (PDF) (https://www.accessda
`Letter (PDF) (https://www.accessda
`Review (https://www.accessdata.fd
`
`Showing 1 to 1 of 1 entries
`
`Supplements
`
`CSV
`
`Excel
`
`
`Action
`Date
`
`Submission
`
`05/19/2014
`
`SUPPL-24
`
`Supplement
`Categories
`or Approval
`Type
`
`Manufacturing
`(CMC)
`
`Letters, Reviews, Labels, Patient Package Insert
`
`08/13/2010
`
`SUPPL-20
`
`Labeling
`
`05/22/2006
`
`SUPPL-18
`
`Labeling
`
`02/10/2004
`
`SUPPL-13
`
`Labeling
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/0212
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/lab
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/
`
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/
`
`02/10/2004
`
`SUPPL-10
`
`Manufacturing
`(CMC)-
`Packaging
`
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/
`
`
`
`Letters, Reviews, Labels, Patient Package Insert
`
`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
`
`Action
`Date
`
`Submission
`
`06/19/2002
`
`SUPPL-8
`
`Supplement
`Categories
`or Approval
`Type
`
`Manufacturing
`(CMC)-Control
`
`04/12/2002
`
`SUPPL-9
`
`Manufacturing
`(CMC)
`
`01/22/2002
`
`SUPPL-7
`
`Manufacturing
`(CMC)
`
`12/20/2001
`
`SUPPL-6
`
`12/18/2001
`
`SUPPL-4
`
`Efficacy-New
`Patient
`Population
`
`Manufacturing
`(CMC)-Control
`
`12/04/2001
`
`SUPPL-5
`
`Manufacturing
`(CMC)
`
`10/23/2001
`
`SUPPL-1
`
`Manufacturing
`(CMC)
`
`
`
`Action
`Date
`
`Submission
`
`10/15/2001
`
`SUPPL-3
`
`Supplement
`Categories
`or Approval
`Type
`
`Manufacturing
`(CMC)-Control
`
`06/05/2001
`
`SUPPL-2
`
`Manufacturing
`(CMC)
`
`Showing 1 to 14 of 14 entries
`
`Labels for NDA 021262
`
`Therapeutic Equivalents for NDA 021262
`
`Letters, Reviews, Labels, Patient Package Insert
`
`
`
`
`
`