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8/16/2017
`
`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=021303)
`
` 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=021303)
`
` 
`
`EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG
`PRODUCTS&BODY=HTTPS://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=OVERVIEW.PROCESS&APPLNO=021303)
`
`Home (index.cfm) | Previous Page
`
`New Drug Application (NDA): 021303
`Company: SHIRE
`
` EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG
`PRODUCTS&BODY=HTTP://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?
`EVENT=OVERVIEW.PROCESS%26VARAPPLNO=021303)
`
`Medication Guide
`(http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021303s032lbl.pdf#page=15)
`
`Other Important Information from FDA
`(http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm11
`1441.htm)
`
`Products on NDA 021303
`
`
`
`CSVExcelPrint
`Drug
`Name
`
`Active Ingredients
`
`Strength
`
`Dosage
`Form/Route
`
`Marketing
`Status
`
`TE
`Code RLD RS
`
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021303
`
`1/4
`
`KVK-TECH EXHIBIT 1013
`
`

`

`8/16/2017
`
`Drugs@FDA: FDA Approved Drug Products
`
`1.25MG;1.25MG;1.25MG;1.25MG CAPSULE,
`EXTENDED
`RELEASE;ORAL
`
`Prescription
`
`AB
`
`Yes
`
`No
`
`7.5MG;7.5MG;7.5MG;7.5MG
`
`CAPSULE,
`EXTENDED
`RELEASE;ORAL
`
`Prescription
`
`AB
`
`Yes
`
`Yes
`
`6.25MG;6.25MG;6.25MG;6.25MG CAPSULE,
`EXTENDED
`RELEASE;ORAL
`
`Prescription
`
`AB
`
`Yes
`
`No
`
`5MG;5MG;5MG;5MG
`
`CAPSULE,
`EXTENDED
`RELEASE;ORAL
`
`Prescription
`
`AB
`
`Yes
`
`No
`
`3.75MG;3.75MG;3.75MG;3.75MG CAPSULE,
`EXTENDED
`RELEASE;ORAL
`
`Prescription
`
`AB
`
`Yes
`
`No
`
`2.5MG;2.5MG;2.5MG;2.5MG
`
`CAPSULE,
`EXTENDED
`RELEASE;ORAL
`
`Prescription
`
`AB
`
`Yes
`
`No
`
`ADDERALL
`XR 5
`
`ADDERALL
`XR 30
`
`ADDERALL
`XR 25
`
`ADDERALL
`XR 20
`
`ADDERALL
`XR 15
`
`AMPHETAMINE
`ASPARTATE;
`AMPHETAMINE
`SULFATE;
`DEXTROAMPHETAMINE
`SACCHARATE;
`DEXTROAMPHETAMINE
`SULFATE
`
`AMPHETAMINE
`ASPARTATE;
`AMPHETAMINE
`SULFATE;
`DEXTROAMPHETAMINE
`SACCHARATE;
`DEXTROAMPHETAMINE
`SULFATE
`
`AMPHETAMINE
`ASPARTATE;
`AMPHETAMINE
`SULFATE;
`DEXTROAMPHETAMINE
`SACCHARATE;
`DEXTROAMPHETAMINE
`SULFATE
`
`AMPHETAMINE
`ASPARTATE;
`AMPHETAMINE
`SULFATE;
`DEXTROAMPHETAMINE
`SACCHARATE;
`DEXTROAMPHETAMINE
`SULFATE
`
`AMPHETAMINE
`ASPARTATE;
`AMPHETAMINE
`SULFATE;
`DEXTROAMPHETAMINE
`SACCHARATE;
`DEXTROAMPHETAMINE
`SULFATE
`
`ADDERALL
`XR 10
`
`AMPHETAMINE
`ASPARTATE;
`AMPHETAMINE
`SULFATE;
`DEXTROAMPHETAMINE
`SACCHARATE;
`DEXTROAMPHETAMINE
`SULFATE
`Showing 1 to 6 of 6 entries
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 021303
`
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021303
`
`
`
`2/4
`
`

`

`8/16/2017
`
`Drugs@FDA: FDA Approved Drug Products
`
`Original Approvals or Tentative Approvals
`CSVExcelPrint
`
`Action
`Date
`
`Submission
`
`Action
`Type
`
`Submission
`Classification
`
`Review
`Priority;
`Orphan
`Status
`
`Letters, Reviews, Labels, Patient Package Insert
`
`10/11/2001 ORIG-1
`
`Approval
`
`Type 3 - New
`Dosage Form
`
`STANDARD Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21303lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21303_Adderall_Approv.pdf)
`Review (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21303_Adderall.cfm)
`
`Showing 1 to 1 of 1 entries
`
`Supplements
`CSVExcelPrint
`Action
`Date
`
`Submission
`
`01/06/2017
`
`SUPPL-32
`
`Submission
`Classification
`
`Labeling-
`Package Insert
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021303s032lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021303Orig1s032,021977Orig1s043ltr.pdf)
`
`04/17/2015
`
`SUPPL-31
`
`Labeling-
`Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021303s031lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021303Orig1s031ltr.pdf)
`
`03/03/2015
`
`SUPPL-28
`
`Manufacturing
`(CMC)
`
`07/24/2014
`
`SUPPL-27
`
`Labeling-
`Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021303s027lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021303Orig1s027ltr.pdf)
`
`12/03/2013
`
`SUPPL-26
`
`Labeling-
`Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021303s026lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021303Orig1s026ltr.pdf)
`
`06/14/2013
`
`SUPPL-24
`
`Labeling-
`Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021303s024lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021303Orig1s024ltr.pdf)
`
`03/08/2013
`
`SUPPL-25
`
`Labeling-
`Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021303s025lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021303Orig1s025ltr.pdf)
`
`02/07/2012
`
`SUPPL-23
`
`Labeling-
`Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021303s023lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021303s023ltr.pdf)
`
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021303
`
`3/4
`
`

`

`8/16/2017
`
`Drugs@FDA: FDA Approved Drug Products
`
`Action
`Date
`
`Submission
`
`Submission
`Classification
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`11/12/2010
`
`SUPPL-22
`
`Labeling-
`Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021303s020s022lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021303s020,s022ltr.pdf)
`
`11/12/2010
`
`SUPPL-20
`
`Labeling
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021303s020s022lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021303s020,s022ltr.pdf)
`
`11/12/2008
`
`SUPPL-19
`
`Labeling
`
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021303s019,021977s008ltr.pdf)
`
`05/22/2007
`
`SUPPL-15
`
`Labeling
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021303s015lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021303s015ltr.pdf)
`
`07/26/2006
`
`SUPPL-13
`
`Labeling
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/011522s034s037,021303s013lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/011522s034, 037,
`021303s013LTR.pdf)
`
`06/16/2006
`
`SUPPL-10
`
`Labeling
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021303s010lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021303s010LTR.pdf)
`
`07/21/2005
`
`SUPPL-9
`
`08/11/2004
`
`SUPPL-5
`
`09/13/2002
`
`SUPPL-3
`
`Efficacy-New
`Patient
`Population
`
`Efficacy-New
`Patient
`Population
`
`Manufacturing
`(CMC)-Control
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021303s009lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021303s009ltr.pdf)
`Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021303Orig1s009.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021303s005lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21303s005ltr.pdf)
`Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021303Orig1s005.pdf)
`
`05/22/2002
`
`SUPPL-1
`
`Manufacturing
`(CMC)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21303s1lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21303s001ltr.pdf)
`Review (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021303_S001_AdderallTOC.cfm)
`
`Showing 1 to 18 of 18 entries
`
`Labels for NDA 021303
`
`Therapeutic Equivalents for NDA 021303
`
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021303
`
`
`
`
`
`4/4
`
`

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