`
`Page 1 of 2
`
`FDA Home3 Drug Databases4 Drugs@FDA5
`
`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
`
`MEXATE
`(ANDA) 086358
`METHOTREXATE SODIUM
`BRISTOL
`September 5, 1979
`
`(cid:122) There are no Therapeutic Equivalents
`
`(cid:122) Labels are not available
`
`(cid:122) Approval History, Letters, Reviews, and
`Related Documents
`
`Products on Application (ANDA) #086358
` Click on a column header to re-sort the table:
`
`Drug Name Active Ingredients
`
`Strength
`
`Dosage Form/Route
`
`MEXATE
`MEXATE
`MEXATE
`MEXATE
`
`METHOTREXATE SODIUM
`METHOTREXATE SODIUM
`METHOTREXATE SODIUM
`METHOTREXATE SODIUM
`
`EQ 20MG BASE/VIAL
`EQ 50MG BASE/VIAL
`EQ 100MG BASE/VIAL
`EQ 250MG BASE/VIAL
`
`INJECTABLE;INJECTION
`INJECTABLE;INJECTION
`INJECTABLE;INJECTION
`INJECTABLE;INJECTION
`
`RLD TE
`Marketing
`Code
`Status
`Discontinued No None
`Discontinued No None
`Discontinued No None
`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.
`Accessibility Contact FDA Careers FDA Basics FOIA No FEAR Act Site Map Transparency Website Policies
`
`http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Drug...
`
`5/22/2016
`
`Medac Exhibit 2015
`Koios Pharmaceuticals v. Medac
`IPR2016-01370
`Page 00001
`
`
`
`Drugs@FDA: FDA Approved Drug Products
`
`Page 2 of 2
`
`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:
`
`http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Drug...
`
`5/22/2016
`
`Page 00002
`
`