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`Additional information:
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`Exclusivity Code
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`1 J~n ~8, 2017
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` EXHIBIT NO. 1061 Page 1
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`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
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`S"earch results from the "OB_Rx" table for query on "020622."
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`Active Ingredient:
`Dosage Form;Route:
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`Product Number:
`Approval Date:
`Reference Listed Drug
`RX/OTC/DISCN:
`TE Code:
`Patent and Exclusivity Info for this product: View
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`GLATIRAMER ACETATE
`INJECTABLE; SUBCUTANEOUS
`COPAXONE
`TEVA PHARMS USA
`20MG/ML
`N020622
`002
`Feb 12, 2002
`Yes
`RX
`
`Active Ingredient:
`Dosage Form;Route:
`Proprietary Name:
`Applicant:
`Strength:
`Application Number:
`Product Number:
`Approval Date:
`Reference Listed Drug
`RX/OTC/DISCN:
`TE Code:
`Patent and Exclusivity Info for this product: View
`
`GLATIRAMER ACETATE
`INJECTABLE; SUBCUTANEOUS
`COPAXONE
`TEVA PHARMS USA
`40MG/ML
`N020622
`003
`Jan 28, 2014
`Yes
`RX
`
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`http://www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.cfm? Appl_ No=020622&T AB... 1/29/2015
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` AMNEAL
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`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
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`Page 1 of2
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`•
`•
`•
`rangeo
`: pproverug Products w1th Therapeutic Eqwvalence
`Evaluations
`S"earch results from the "OB_Rx" table for query on "020622."
`
`Active Ingredient:
`Dosage Form;Route:
`Proprietary Name:
`Applicant:
`Strength:
`Application Number:
`Product Number:
`Approval Date:
`Reference Listed Drug
`RX/OTC/DISCN:
`TE Code:
`Patent and Exclusivity Info for this product: View
`
`GLATIRAMER ACETATE
`INJECTABLE;SUBCUTANEOUS
`COPAXONE
`TEVA PHARMS USA
`20MG/ML
`N020622
`002
`Feb 12, 2002
`Yes
`RX
`
`Active Ingredient:
`Dosage Form;Route:
`Proprietary Name:
`Applicant:
`Strength:
`Application Number:
`Product Number:
`Approval Date:
`Reference Listed Drug
`RX/OTC/DISCN:
`TE Code:
`Patent and Exclusivity Info for this product: View
`
`GLATIRAMER ACETATE
`INJECTABLE; SUBCUTANEOUS
`COPAXONE
`TEVA PHARMS USA
`40MG/ML
`N020622
`003
`Jan 28, 2014
`Yes
`RX
`
`Return to Electronic Orange Book Home Page6
`
`FDA/Center for Drug Evaluation and Research
`Office of Generic Drugs
`Division of Labeling and Program Support
`Update Frequency:
`Orange Book Data - Monthly
`Generic Drug Product Information & Patent Information - Daily
`Orange Book Data Updated Through December 2014
`Patent and Generic Drug Product Data Last Updated January 29, 2015
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` EXHIBIT NO. 1061 Page 5
`http:/ /www.accessdata.fdaogov/scripts/cder/ob/docs/obdetail.cfin? Appl_ No=020622&T ABO 0 0
`1/29/2015
`
` AMNEAL
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`
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`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`Page 1 of2
`
`I
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`1-
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`(9A Home3 ~ru~~a)\bases4 Ora8 gO Book5
`•
`•
`•
`rangeo :pproverug Products w1th Therapeutic Equivalence
`Evaluations
`S"earch results from the "OB_Rx" table for query on "020622."
`
`Active Ingredient:
`Dosage Form; Route:
`Proprietary Name:
`Applicant:
`Strength:
`Application Number:
`Product Number:
`Approval Date:
`Reference Listed Drug
`RX/OTC/DISCN:
`TE Code:
`Patent and Exclusivity Info for this product: View
`
`GLATIRAMER ACETATE
`INJECTABLE;SUBCUTANEOUS
`COPAXONE
`TEVA PHARMS USA
`20MG/ML
`N020622
`002
`Feb 12, 2002
`Yes
`RX
`
`Active Ingredient:
`Dosage Form;Route:
`Proprietary Name:
`Applicant:
`Strength:
`Application Number:
`Product Number:
`Approval Date:
`Reference Listed Drug
`RX/OTC/DISCN:
`TE Code:
`Patent and Exclusivity Info for this product: View
`
`GLATIRAMER ACETATE
`INJECTABLE;SUBCUTANEOUS
`COPAXONE
`TEVA PHARMS USA
`40MG/ML
`N020622
`003
`Jan 28, 2014
`Yes
`RX
`
`Return to Electronic Orange Book Home Page6
`
`FDA/Center for Drug Evaluation and Research
`Office of Generic Drugs
`Division of Labeling and Program Support
`Update Frequency:
`Orange Book Data - Monthly
`Generic Drug Product Information & Patent Information - Daily
`Orange Book Data Updated Through December 2014
`Patent and Generic Drug Product Data Last Updated January 29, 2015
`
`Links on this page:
`1. http:/ jwww.addthis.com/bookmark.php?
`u 508=true&v= 152&userna me=fdamain
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` EXIITBIT NO. 1061 Page 6
`http:/ /www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.cfm? Appl_ No=020622&T AB... 1129/2015
`
` AMNEAL
`
`
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`Page 2 of2
`
`2. http:/ jwww.addthis .com/bookmark.php
`
`3 . http://www.fda.gov/default.htm
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`4. http ://www. fda .gov /Drugs/InformationOnDrugs/defau it. htm
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`
`../default.cfm
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`
`../default.cfm
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`Ph. 1-888-INFO-FDA (1-888-463-6332)
`Emai l FDA
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`For Government For Press
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` EXHIBIT NO. 1061 Page 7
`http:/ /www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.cfm? Appl_ No=020622&TAB.. . 1/29/2015
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` AMNEAL