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Drugs@FDA: FDA Approved Drug Products
`
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process
`
`SHARE (HTTPS://WWW.FACEBOOK.COM/SHARER/SHARER.PHP?U=HTTPS://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=BASICSEARCH.PROCESS)
`
`TWEET (HTTPS://TWITTER.COM/INTENT/TWEET/?TEXT=DRUGS@FDA: FDA APPROVED DRUG PRODUCTS&URL=HTTPS://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=BASICSEARCH.PROCESS)
`
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`UG PRODUCTS&SOURCE=FDA)
`
`PIN IT (HTTPS://WWW.PINTEREST.COM/PIN/CREATE/BUTTON/?URL=HTTPS://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=BASICSEARCH.PROCESS&DESCRIPTION=DRUGS@FDA: FDA APPROVED DR
`UG PRODUCTS)
`
`EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG PRODUCTS&BODY=HTTPS://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=BASICSEARCH.PROCESS)
`
`PRINT
`
`Home (index.cfm) | Previous Page
`
`New Drug Application (NDA): 020067
`Company: ATNAHS PHARMA US
`
`EMAIL (MAILTO:?SUBJE
`CT=DRUGS@FDA: FDA APP
`ROVED DRUG PRODUCTS&B
`ODY=HTTP://WWW.ACCESS
`DATA.FDA.GOV/SCRIPTS/CD
`ER/DAF/INDEX.CFM?EVENT=
`OVERVIEW.PROCESS%26VA
`RAPPLNO=020067)
`
`Medication Guide (http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017581s113,018164s063,020067s020lbl.pdf#page=22)
`
`Products on NDA 020067
`
`1 of 5
`
`8/23/17, 9:33 AM
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`MYLAN PHARMS. INC. EXHIBIT 1008 PAGE 1
`
`

`

`Drugs@FDA: FDA Approved Drug Products
`
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process
`
`CSVExcelPrint
`
`Drug Name
`
`Active Ingredients
`
`Strength
`
`Dosage Form/Route
`
`Marketing Status
`
`TE Code
`
`RLD
`
`EC-NAPROSYN
`
`NAPROXEN
`
`EC-NAPROSYN
`
`NAPROXEN
`
`Showing 1 to 2 of 2 entries
`
`375MG
`
`500MG
`
`TABLET, DELAYED RELEASE;ORAL
`
`Prescription
`
`TABLET, DELAYED RELEASE;ORAL
`
`Prescription
`
`AB
`
`AB
`
`Yes
`
`Yes
`
`RS
`
`Yes
`
`Yes
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 020067
`
`Original Approvals or Tentative Approvals
`CSVExcelPrint
`
`Action Date
`
`Submission
`
`Action Type
`
`Submission Classification
`
`Review Priority;
`Orphan Status
`
`Letters, Reviews,
`Labels, Patient
`Package Insert
`
`10/14/1994
`
`ORIG-1
`
`Approval
`
`Type 3 - New Dosage Form
`
`STANDARD
`
`Notes
`
`Label is not
`available on this
`site.
`
`Showing 1 to 1 of 1 entries
`
`Supplements
`CSVExcelPrint
`
`Action Date
`
`Submission
`
`Submission
`Classification
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`Note
`
`2 of 5
`
`8/23/17, 9:33 AM
`
`MYLAN PHARMS. INC. EXHIBIT 1008 PAGE 2
`
`

`

`Drugs@FDA: FDA Approved Drug Products
`
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process
`
`Action Date
`
`Submission
`
`03/10/2017
`
`SUPPL-20
`
`Submission
`Classification
`
`Labeling-Package
`Insert
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`Note
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label
`/2017/017581s113,018164s063,020067s020lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter
`/2017/017581Orig1s113,018164Orig1s063,020067Orig1s020ltr.pdf)
`
`05/09/2016
`
`SUPPL-19
`
`Labeling-Medication
`Guide, Labeling-
`Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label
`/2016/017581s112,018164s062,020067s019lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter
`/2016/017581Orig1s112,018164Orig1s062,020067Orig1s019ltr.pdf)
`
`03/22/2013
`
`SUPPL-18
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label
`/2013/017581s111,018164s061,018965s020,020067s018lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter
`/2013/017581Orig1s111,018164Orig1s061,018965Orig1s020,020067Orig1s018ltr.pdf)
`
`07/25/2008
`
`SUPPL-17
`
`Labeling
`
`09/20/2007
`
`SUPPL-14
`
`Labeling
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label
`/2008/017581s110,18164s60,18965s18,20067s17lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter
`/2008/017581s110,018164s060,018965s018,020067s017ltr.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label
`/2007/017581s108,18164s58,18965s16,20067s14lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter
`/2007/017581s108,18164s58,18965s16,20067s14ltr.pdf)
`
`04/19/2007
`
`SUPPL-13
`
`Labeling
`
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017581s107,
`018164s057, 018965s015, 020067s013_ltr.pdf)
`
`Label is not
`available
`on this site.
`
`03/10/2006
`
`SUPPL-10
`
`Labeling
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label
`/2006/020067s010,018965s013,018164s055, 017581s105lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020067s010ltr.pdf)
`
`01/24/2006
`
`SUPPL-11
`
`Labeling
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label
`/2006/017581s106,018164s056,018965s014,020067s011lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter
`/2006/017581s106_020067s011_018164s056ltr.pdf)
`
`3 of 5
`
`8/23/17, 9:33 AM
`
`MYLAN PHARMS. INC. EXHIBIT 1008 PAGE 3
`
`

`

`Drugs@FDA: FDA Approved Drug Products
`
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process
`
`Action Date
`
`Submission
`
`Submission
`Classification
`
`11/10/2004
`
`SUPPL-6
`
`Labeling
`
`11/10/2004
`
`SUPPL-4
`
`Labeling
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`Note
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label
`/2004/17581s99,100,18164s50,51,18965s9,10,20067s4,6lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter
`/2004/17581s99,100,18164s50,51,18965s9,10,20067s4,6ltr.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label
`/2004/17581s99,100,18164s50,51,18965s9,10,20067s4,6lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter
`/2004/17581s99,100,18164s50,51,18965s9,10,20067s4,6ltr.pdf)
`
`05/19/2003
`
`SUPPL-5
`
`Labeling
`
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20067slr005ltr.pdf)
`
`02/22/2002
`
`SUPPL-9
`
`11/09/2001
`
`SUPPL-8
`
`07/09/1997
`
`SUPPL-3
`
`06/28/1996
`
`SUPPL-2
`
`12/06/1994
`
`SUPPL-1
`
`Showing 1 to 16 of 16 entries
`
`Manufacturing
`(CMC)
`
`Manufacturing
`(CMC)-Packaging
`
`Manufacturing
`(CMC)
`
`Manufacturing
`(CMC)
`
`Manufacturing
`(CMC)
`
`Label is not
`available
`on this site.
`
`Label is not
`available
`on this site.
`
`Label is not
`available
`on this site.
`
`Label is not
`available
`on this site.
`
`Label is not
`available
`on this site.
`
`Label is not
`available
`on this site.
`
`4 of 5
`
`8/23/17, 9:33 AM
`
`MYLAN PHARMS. INC. EXHIBIT 1008 PAGE 4
`
`

`

`Drugs@FDA: FDA Approved Drug Products
`
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process
`
`Labels for NDA 020067
`
`Therapeutic Equivalents for NDA 020067
`
`5 of 5
`
`8/23/17, 9:33 AM
`
`MYLAN PHARMS. INC. EXHIBIT 1008 PAGE 5
`
`

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