`
`FAQ6 | Instructions7 | Glossary8 | Contact Us9
`
`Email Link
`
`Drug Details
`
`Drug Name(s)
`FDA Application No.
`Active Ingredient(s)
`Company
`Original Approval or Tentative Approval Date
`Chemical Type
`Review Classification
`
`ACULAR PRESERVATIVE FREE
`(NDA) 020811
`KETOROLAC TROMETHAMINE
`ALLERGAN
`November 3, 1997
`3 New dosage form
`S Standard review drug
`
`(cid:122) There are no Therapeutic Equivalents
`
`(cid:122) Label Information
`
`(cid:122) Approval History, Letters, Reviews, and
`Related Documents
`
`Products on Application (NDA) #020811
` Click on a column header to re-sort the table:
`
`Drug Name
`
`Active Ingredients
`
`ACULAR PRESERVATIVE
`FREE
`
`KETOROLAC
`TROMETHAMINE
`
`0.5%
`
`StrengthDosage Form/Route
`
`RLDTE
`Marketing
`Code
`Status
`SOLUTION/DROPS;OPHTHALMIC Discontinued No None
`
`Back to Top | Back to Previous Page | Back to Drugs@FDA Home
`Disclaimer10
`
`FDA/Center for Drug Evaluation and Research
`Office of Communications
`Division of Online Communications
`Update Frequency: Daily
`
`Links on this page:
`1. http://www.addthis.com/bookmark.php?u508=true&v=152&username=fdamain
`2. http://www.addthis.com/bookmark.php
`3. http://www.fda.gov/default.htm
`4. http://www.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://www.fda.gov/Drugs/InformationOnDrugs/UCM079874
`8. http://www.fda.gov/Drugs/InformationOnDrugs/ucm079436.htm
`9. http://www.accessdata.fda.gov/scripts/email/cder/commentdrugcat.cfm
`10. http://www.fda.gov/AboutFDA/AboutThisWebsite/WebsitePolicies/default.htm#web
`
`Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
`
`SENJU EXHIBIT 2061
`LUPIN v. SENJU
`IPR2015-01097
`
`Page 1 of 2
`
`
`
`Accessibility Contact FDA Careers FDA Basics FOIA No Fear Act Site Map Transparency Website Policies
`
`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
`
`For Government For Press
`Combination Products Advisory Committees Science & Research Regulatory Information Safety Emergency
`Preparedness International Programs News & Events Training and Continuing Education Inspections/Compliance State &
`Local Officials Consumers Industry Health Professionals FDA Archive
`
`Links on this page:
`
`Page 2 of 2