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5/28/2019
`
`Drugs@FDA: FDA Approved Drug Products
`
`Drugs@FDA: FDA Approved Drug Products
`
` SHARE (HTTPS://WWW.FACEBOOK.COM/SHARER/SHARER.PHP?U=HTTPS://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=OVERVIEW.PROCESS&APPLNO=077356)
`
` 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=OVERVIEW.PROCESS&APPLNO=077356)
`
` LINKEDIN (HTTPS://WWW.LINKEDIN.COM/SHAREARTICLE?MINI=TRUE&URL=HTTPS://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?
`EVENT=OVERVIEW.PROCESS&APPLNO=077356&TITLE=DRUGS@FDA: FDA APPROVED DRUG PRODUCTS&SOURCE=FDA)
`
` PIN IT (HTTPS://WWW.PINTEREST.COM/PIN/CREATE/BUTTON/?URL=HTTPS://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?
`EVENT=OVERVIEW.PROCESS&APPLNO=077356&DESCRIPTION=DRUGS@FDA: FDA APPROVED DRUG PRODUCTS)
`
` 
`
`EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG PRODUCTS&BODY=HTTPS://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?
`EVENT=OVERVIEW.PROCESS&APPLNO=077356)
`
` PRINT
`
`Home (index.cfm) | Previous Page
`
`Abbreviated New Drug Application (ANDA): 077356
`Company: TEVA PHARMS USA
`
` EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG PRODUCTS&BODY=HTTP://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?
`EVENT=OVERVIEW.PROCESS%26VARAPPLNO=077356)
`
`Products on ANDA 077356
`
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=077356
`
`
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`1/5
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`Biogen Exhibit 2168
`Mylan v. Biogen
`IPR 2018-01403
`
`Page 1 of 5
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`

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`5/28/201 9
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`Drugs@FDA: FDA Approved Drug Products
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`CSV
`
`Excel
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`Print
`
`Drug Name
`
`Ingredients
`
`Strength
`
`Active
`
`Dosage
`
`Form/Route
`
`Marketing
`
`Status
`
`TE
`
`Code
`
`RLD
`
`RS
`
`MITOXANTRONE
`HYDROCHLORIDE
`
`MITOXANTRONE
`HYDROCHLORIDE
`
`EO 20MG BASEI10ML
`(EQ 2M6 BASEIML)
`
`INJECTABLE;INJECTION
`
`Prescription
`
`MITOXANTRONE
`HYDROCHLORIDE
`
`MITOXANTRONE
`HYDROCHLORIDE
`
`EQ 25m;
`BASE/12.5ML (EQ 2M6
`BASE/ML)
`
`INJECTABLE;INJECTION
`
`Pre cription
`
`AP
`
`AP
`
`NO
`
`NO
`
`NO
`
`No
`
`MITOXANTRONE
`HYDROCHLORIDE
`
`MITOXANTRONE
`HYDROCHLORIDE
`
`EQ some BASE/15ML
`(EQ 2MG BASEIML)
`
`INJECTABLE;INJECTION
`
`Prescription
`
`AP
`
`No
`
`No
`
`Showing 1 to 3 Of 3 entries
`
`Approval Date(§) and History, Letters, Labels, Reviews for ANDA 077356
`
`Therapeutic Equivalents for ANDA 077356
`
`MITOXANTRONE HYDROCHLORIDE
`
`INJECTABLE;INJECTION; EQ 20MG BASE/10ML (EQ 2M6 BASE/ML)
`TE Code = AP
`
`CSV
`
`Excel
`
`Print
`
`v
`
`A
`
`Drug Name
`
`Ingredients
`
`Strength
`
`Dosage FonnIRoute
`
`Status
`
`RLD
`
`Active
`
`Marketing
`
`TE
`
`Code
`
`Application No
`
`MITOXANTRONE
`HYDROCHLORIDE
`
`MITOXANTRONE
`HYDROCHLORIDE
`
`EQ 20MG
`BASE/10ML
`
`INJECTABLE;INJECTION
`
`Prescription
`
`No
`
`AP
`
`MIMIW
`event=overview.processaiApnl
`
`(EQ 2MG
`BASE/ML)
`
`Page 2 of 5
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`2/5
`
`

`

`5/28/201 9
`
`Drugs@FDA: FDA Approved Drug Products
`
`Drug Name
`
`Ingredients
`
`Strength
`
`Dosage Form/Route
`
`Status
`
`RLD
`
`Code
`
`Application No
`
`Active
`
`Marketing
`
`TE
`
`MITOXANTRONE
`HYDROCHLORIDE
`
`MITOXANTRONE
`HYDROCHLORIDE
`
`MITOXANTRONE
`HYDROCHLORIDE
`
`MITOXANTRONE
`HYDROCHLORIDE
`
`EQ 20MG
`BASEI1OML
`(EQ 2MG
`BASE/ML)
`
`EQ 20MG
`BASE/10ML
`(EQ 2MG
`BASE/ML)
`
`INJECTABLE;INJECTION
`
`Prescription
`
`No
`
`AP
`
`Mlmtwdaflmdt
`event=overview.process&Apll
`
`INJECTABLE;INJECTION
`
`Prescription
`
`No
`
`AP
`
`201014 (Iscrigtslcderldaflindt
`WIMP]
`
`MITOXANTRONE
`HYDROCHLORIDE
`
`MITOXANTRONE
`HYDROCHLORIDE
`
`EQ 20MG
`BASEI10ML
`
`INJECTABLE;INJECTION
`
`Prescription
`
`No
`
`AP
`
`077356
`
`MITOXANTRONE
`HYDROCHLORIDE
`
`MITOXANTRONE
`HYDROCHLORIDE
`
`Showing 1 to 5 of 5 entries
`
`(EQ 2MG
`BASEIML)
`
`EQ 20MG
`BASE/10ML
`(EQ 2MG
`BASEIML)
`
`INJECTABLE;INJECTION
`
`Prescription
`
`No
`
`AP
`
`076611 (Iscrigtslcderldaflinde
`WIMP]
`
`INJECTABLE;INJECTION; EQ 25MG BASE/12.5ML (EQ 2M6 BASEIML)
`TE Code = AP
`
`CSV
`
`Excel
`
`Print
`
`Drug Name
`
`Ingredients
`
`Strength
`
`Dosage FomIIRoute
`
`Status
`
`RLD
`
`Active
`
`Marketing
`
`TE
`
`Code
`
`Application N
`
`Page 3 of 5
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`3/5
`
`

`

`5/28/201 9
`
`Drugs@FDA: FDA Approved Drug Products
`
`Drug Name
`
`Ingredients
`
`Strength
`
`Dosage FomIIRoute
`
`Status
`
`RLD
`
`Code
`
`Application N
`
`Active
`
`Marketing
`
`TE
`
`MITOXANTRONE
`HYDROCHLORIDE
`
`MITOXANTRONE
`HYDROCHLORIDE
`
`MITOXANTRONE
`HYDROCHLORIDE
`
`MITOXANTRONE
`HYDROCHLORIDE
`
`EQ 25MG
`BASE/12.5ML
`(EQ 2MG
`BASE/ML)
`
`EQ 25MG
`BASE/12.5ML
`(EQ 2MG
`BASE/ML)
`
`INJECTABLE;INJECTION
`
`Prescription
`
`No
`
`AP MQSEEW:
`event=overview.process&Al
`
`INJECTABLE;INJECTION
`
`Prescription
`
`No
`
`AP
`
`076871 llscrigtslcderldaflinc
`event=overVIewprocess&Al
`
`MITOXANTRONE
`HYDROCHLORIDE
`
`MITOXANTRONE
`HYDROCHLORIDE
`
`EQ 25MG
`BASE/12.5ML
`
`INJECTABLE;INJECTION
`
`Prescription
`
`No
`
`AP
`
`077356
`
`MITOXANTRONE
`HYDROCHLORIDE
`
`MITOXANTRONE
`HYDROCHLORIDE
`
`Showing 1 to 4 of 4 entries
`
`(EQ 2MG
`BASEIML)
`
`EQ 25MG
`BASE/12.5ML
`(EQ 2MG
`BASEIML)
`
`INJECTABLE;INJECTION
`
`Prescription
`
`No
`
`AP
`
`076611 llscrigtslcderldaflind
`WW|
`
`INJECTABLE;INJECTION; EQ 30MG BASEI15ML (EQ ZMG BASEIML)
`TE Code = AP
`
`CSV
`
`Excel
`
`Print
`
`Drug Name
`
`Ingredients
`
`Strength
`
`Dosage FonnIRoute
`
`Status
`
`RLD
`
`Active
`
`Marketing
`
`TE
`
`Code
`
`Application No
`
`Page 4 of 5
`https:Ilwww_accessdatajda_gov/scriplslcderldaffindex.cfm?event=overview_process&ApplNo=077356
`
`4/5
`
`

`

`5/28/201 9
`
`Drugs@FDA: FDA Approved Dmg Products
`
`Drug Name
`
`Ingredients
`
`Strength
`
`Dosage FonnIRoute
`
`Active
`
`Marketing
`Status
`
`TE
`
`RLD
`
`Code
`
`MITO ANTRONE
`HYDROCHLORIDE
`
`MITO ANTRONE
`HYDROCHLORIDE
`
`EQ 30MG
`BASE/15ML
`
`INJECTABLE;INJECTION
`
`Pre cription
`
`No
`
`AP
`
`Application No
`
`mil-“MW
`event=overview.process&Ap'|
`
`(EQ 2MG
`BASE/ML)
`
`MITOXANTRONE
`HYDROCHLORIDE
`
`MITOXANTRONE
`HYDROCHLORIDE
`
`EQ 30MG
`BASE/15ML
`
`|NJECTABLE;INJECTION
`
`Prescription
`
`No
`
`AP
`
`076871 (Iscrigtslcderldaflinde
`WWW
`
`(EQ 2MG
`BASE/ML)
`
`MITOXANTRONE
`HYDROCHLORIDE
`
`M ITOXANTRONE
`HYDROCHLORIDE
`
`EQ some
`BASEI15ML
`
`INJECTABLE;INJECTION
`
`Prescription
`
`No
`
`AP
`
`077356
`
`(EQ ZMG
`BASEIML)
`
`MITOXANTRONE
`HYDROCHLORIDE
`
`MITOXANTRONE
`HYDROCHLORIDE
`
`EQ 30MG
`BASE/15ML
`
`INJECTABLE;INJECTION
`
`Prescription
`
`No
`
`AP
`
`076611 (Iscrigtslcderldaflinde
`WIMP]
`
`(EQ 2MG
`BASE/ML)
`
`Showing 1 to 4 of 4 entrie
`
`Page 5 of 5
`https:Ilwww_accessdatafda_gov/scnplslcderldaffindex_cfm?event=overview_pmess&ApplNo=077356
`
`5/5
`
`

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