`
`Drugs@FDA: FDAAAlrcMid Drug l'roct.JdB
`
`EPA Homel PM Databases" prugs®FDA5
`
`Drugs@
`
`FDA Approved Drug Products
`
`FAQ6 I lnstructlons7 I Glossary8 I Contact Us9
`
`~Email Link
`
`Start Over
`
`Back to Search Results
`
`Back to Overview
`
`Drug Detai Is
`
`Drug Name(s)
`FDA Appllcatfon No.
`Active lngredlent(s)
`Company
`Original Approval or Tentat1ve Approval Date
`Chemical Type
`Review Classification
`
`ALPHAGAN P
`(NDA) 021262
`BRIMONIDINE TARTRATE
`AU.ERGAN
`March 16, 2001
`3 New dosage form
`S Standard review drug
`
`• Therapeutic Equivalents
`
`• Label Information
`
`• Approval History, Letters, Reviews, and Related
`Documents
`
`Products on Application (NDA) #021262
`Click on a column header to re·IIC»rt the table:
`
`Drug Name Active Ingredients
`
`strength Dosage Form/Route
`
`ALPHAGAN P
`
`BRIMONIDINE TARTRATE
`
`0.15%
`
`SOWTION/DROPS;OPHTHALMIC
`
`Marketing
`Status
`Prescription
`
`RLDTE
`Code
`Yes AT
`
`Back to Top I Back to Previous Page I Back to Drugs@FDA Home
`Disclaimer10
`
`FDNCenter for Drug Evaluation and Research
`Office of Communications
`Division of Online Communications
`Update Frequency: Dally
`
`Links on this page:
`1. http://www .addthis.com/bookmark. php?u508=true&v= 152&username=fdamai n
`
`2. http://www.addthis.com/bookmark. php
`
`3. http:/fwww.fda.gov/default.htm
`
`4. http://www.fda .gov/Drugs/lnformationOnDrugs/defa ult.htm
`
`5. http://www .accessdata. fda.gov/scripts/cder/drugsatfda/i ndex.cfm
`
`6. http://www.fda .gov/Drugs/1 nformatlonOnDrugsfucm075234. htm
`
`7. http://www. fda .gov/Drugs/1 nformatlonOnDrugs/UCM079874
`
`8. http://www.fda .gov/Drugs/lnformationOnDrugs/ucm079436. htm
`
`9. http://www .accessdata. fda.gov/scripts/emai 1/cder/commentdrugcat.cfm
`
`10. http://www .fda .gov/ About:FDN AboutThlsWebslte/WebsltePollcles/default. htm #web
`
`Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
`Accessibility Contact FDA careers FDA Basics FOIA No Fear Act Site Map Transparency Website Policies
`
`1/2
`
`Page 1 of 2
`
`SENJU EXHIBIT 2092
`LUPIN v. SENJU
`IPR2015-01097
`
`
`
`1012312015
`U.S. Food and Drug Administration
`10903 New Hampshire Avenue
`Silver Spring, MD 20993
`Ph. 1-888-INFO-FDA (1-888-463-6332)
`Contact FDA
`
`Drugs@FDA: FDA Approved Drug Products
`
`For Government For Press
`Combination Products Advisory Committees Science & Research Regulatory Information Safety Emergency Preparednes:
`International Programs News & Events Training and Continuing Education Inspections/Compliance State & Local Officials
`Consumers Industry Health Professionals FDA Archive
`
`4 U.S. Department of Health 8t Huma n Services
`
`Links on this page:
`1. http :ffwww .addthis.com/bookmark. php?u50B=true&v= 152&username=fdamai n
`
`2. http://www .addthis.com/bookmark. php
`
`3. http://www.fda.gov/default.htm
`
`4. http :ffwww. fda. gov /Drugs/InformationOnDrugs/default. htm
`
`5. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
`
`6. http://www. fda. gov /Drugs/InformationOnDrugs/ucm075234. htm
`
`7. http :ffwww. fda. gov /Drugs/InformationOnDrugs/UCM079874
`
`B. http://www. fda. gov /Drugs/InformationOnDrugs/ucm079436. htm
`
`9. http://www.accessdata.fda.gov/scripts/email/cder/commentdrugcat.cfm
`10. http :ffwww. fda. gov I AboutFDA/ AboutThisWebsite/WebsitePol icies/defa ult. htm #web
`
`https:ltwww.accessdal:a.fda.gov/scriJU!cder/drugsalfdafindax.cfm?fuseactim=SeErch.DrugDel:ails
`
`212
`
`Page 2 of 2