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`Methergine [Methylergonovine Maleate) Tablets 8:
`Injection, Rx
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`ANDA 40-529
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`Lannctt Company
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`MethocarbamolTabletsUSP,500St‘I50mg,Rx
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`Methocarbamcl Tablets USP, 500 & 750 mg, Rx
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`VintagePharmaceuticals,Inc.
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`Able Laboratories. Inc.
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`ANDA40489
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`ANDA 40-413
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`Methotrexate Sodium Injection. Rx
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`Wyeth Pharmaceuticals
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`NDA 1 1571915106
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`Wycth~Aycrst Laboratories
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`NDA 1 1-7 l9!S-104
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`Methotrexate Injection USP, 25 mg.n'mL, 2 mL & 10
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`Bigmar Inc.
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`Methotrexate Injection USP, 25 mgfmL in vials of 50 Bigmar Inc.
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`Page 1 of 82
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`KOIOS Exhibit 1021
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`Page 1 of 82
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`KOIOS Exhibit 1021
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`

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`
`
`https://web.archive.org/web/20041210024809/http://www.fda.gov/CDER/foi/label/2004/11719slr106_methotrexate_lbl.pdfhttps://web.archive.org/web/20041210024809/http://www.fda.gov/CDER/foi/label/2004/11719slr106_methotrexate_lbl.pdf
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`Page 2 of 82
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`!
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`KOIOS Exhibit 1021
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`!
`
`

`
`https://web.archive.org/web/20041210024809/http://www.fda.gov/CDER/foi/label/2004/11719slr106_methotrexate_lbl.pdf
`
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`Page 3 of 82
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`1
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`KOIOS Exhibit 1021
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`!
`
`

`
`https://web.archive.org/web/20041210024809/http://www.fda.gov/CDER/foi/label/2004/11719slr106_methotrexate_lbl.pdf
`
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`Page 4 of 82
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`A
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`KOIOS Exhibit 1021
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`!
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`

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`https://web.archive.org/web/20041210024809/http://www.fda.gov/CDER/foi/label/2004/11719slr106_methotrexate_lbl.pdf
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`$UD!1?LSGBESM!&JMDPDRZ!6EDNK!HBNLS?H!9DJ?!EGJLDTS^?L!GJL!DJ?!JDJ\EGJLDTS^?L:!L?TDJHBEGB?L!
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`UC?J!CSRC!LDH?!T?BCDBE?FGB?!USBC!P?NMDVDESJ!E?HMN?!UGH!NH?L!SJ!MDTISJGBSDJ!USBC!DBC?E!
`MC?TDBC?EGK?NBSM!GR?JBH!ODPPDUSJR!HNERSMGP!E?H?MBSDJ!DO!BC?!KESTGEZ!BNTDE8!$C?H?!HBNLS?H!U?E?!
`JDB!L?HSRJ?L!BD!L?TDJHBEGB?!BC?!HK?MSOSM!MDJBESINBSDJ!DO!CSRC!LDH?!T?BCDBE?FGB?QP?NMDVDESJ!
`E?HMN?!BC?EGKZ!BD!BC?!?OOSMGMZ!DO!BC?!MDTISJGBSDJ8!%DU?V?E<!G!MDJBESINBSDJ!MGJ!I?!SJO?EE?L!OEDT!
`BC?!E?KDEBH!DO!DIj?MBSV?!E?HKDJH?H!BD!BCSH!BC?EGKZ!SJ!KGBS?JBH!USBC!T?BGHBGBSM!DHB?DHGEMDTG<!GJL!
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`KGBS?JBH!USBC!JDJ\T?BGHBGBSM!DHB?DHGEMDTG8!
`
`Page 5 of 82
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`KOIOS Exhibit 1021
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`!
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`

`
`https://web.archive.org/web/20041210024809/http://www.fda.gov/CDER/foi/label/2004/11719slr106_methotrexate_lbl.pdf
`
`9<=>?=@3AB4CDB@E)
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`
`"?BCDBE?FGB?!LD?H!JDB!K?J?BEGB?!BC?!IPDDL\M?E?IEDHKSJGP!OPNSL!IGEES?E!SJ!BC?EGK?NBSM!GTDNJBH!
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`
`2J!LDRH<!HZJDVSGP!OPNSL!MDJM?JBEGBSDJH!GOB?E!DEGP!LDHSJR!U?E?!CSRC?E!SJ!SJOPGT?L!BCGJ!NJSJOPGT?L!
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`
`Page 6 of 82
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`KOIOS Exhibit 1021
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`!
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`

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`https://web.archive.org/web/20041210024809/http://www.fda.gov/CDER/foi/label/2004/11719slr106_methotrexate_lbl.pdf
`
`4"%$B.=&0-!l!)OB?E!GIHDEKBSDJ<!T?BCDBE?FGB?!NJL?ERD?H!C?KGBSM!GJL!SJBEGM?PPNPGE!T?BGIDPSHT!BD!
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`DEGP!GLTSJSHBEGBSDJ8!
`
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`
`"?BCDBE?FGB?!MP?GEGJM?!EGB?H!VGEZ!USL?PZ!GJL!GE?!R?J?EGPPZ!L?ME?GH?L!GB!CSRC?E!LDH?H8!-?PGZ?L!
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`
`$C?!KDB?JBSGP!ODE!BDFSMSBZ!OEDT!CSRC!LDH?!E?RST?JH!DE!L?PGZ?L!?FME?BSDJ!SH!E?LNM?L!IZ!BC?!
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`&-0)+),(#&()*+8!
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`"?BCDBE?FGB?!CGH!I??J!L?B?MB?L!SJ!CNTGJ!IE?GHB!TSPW8!$C?!CSRC?HB!IE?GHB!TSPW!BD!KPGHTG!
`MDJM?JBEGBSDJ!EGBSD!E?GMC?L!UGH!g8gc;A8!
`
`Page 7 of 82
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`KOIOS Exhibit 1021
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`!
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`

`
`https://web.archive.org/web/20041210024809/http://www.fda.gov/CDER/foi/label/2004/11719slr106_methotrexate_lbl.pdf
`
`,/+,1(#,%/*)(/+)-*(8")
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`
`Page 8 of 82
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`KOIOS Exhibit 1021
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`https://web.archive.org/web/20041210024809/http://www.fda.gov/CDER/foi/label/2004/11719slr106_methotrexate_lbl.pdf
`
`1%/#&(,/+,1(#,%/*)
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`$C?!MPSJSMGP!KCGETGMDPDRZ!DO!T?BCDBE?FGB?!CGH!JDB!I??J!U?PP!HBNLS?L!SJ!DPL?E!SJLSVSLNGPH8!-N?!BD!
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`Page 9 of 82
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`KOIOS Exhibit 1021
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`https://web.archive.org/web/20041210024809/http://www.fda.gov/CDER/foi/label/2004/11719slr106_methotrexate_lbl.pdf
`
`*DT?!DO!BC?!?OO?MBH!T?JBSDJ?L!NJL?E!(+O"&*")&"(1#,%/*<!HNMC!GH!LS^^SJ?HH!GJL!OGBSRN?<!
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`
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`RGHBEDSJB?HBSJGP!BDFSMSBZ8!
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`Page 10 of 82
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`KOIOS Exhibit 1021
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`https://web.archive.org/web/20041210024809/http://www.fda.gov/CDER/foi/label/2004/11719slr106_methotrexate_lbl.pdf
`
`3GNBSDJ!HCDNPL!I?!NH?L!UC?J!/*)2-H!GJL!HGPSMZPGB?H!GE?!GLTSJSHB?E?L!MDJMDTSBGJBPZ!USBC!PDU?E!
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`=SBGTSJ!KE?KGEGBSDJH!MDJBGSJSJR!ODPSM!GMSL!DE!SBH!L?ESVGBSV?H!TGZ!L?ME?GH?!E?HKDJH?H!BD!
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`Page 11 of 82
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`KOIOS Exhibit 1021
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`!
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`https://web.archive.org/web/20041210024809/http://www.fda.gov/CDER/foi/label/2004/11719slr106_methotrexate_lbl.pdf
`
`7DPGB?!L?OSMS?JMZ!HBGB?H!TGZ!SJM