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`FDA Home3 Drugs4 Drug Approvals and Databases5 Drugs@FDA6
`Drug Approval Package
`Strattera (Atomoxetine Hydrochloride) Capsules
`Company: Eli Lilly & Co.
`Application No.: 21-411
`Approval Date: 11/26/2002
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`• Approval Letter(s) (PDF)
`• Printed Labeling (PDF)
`• Medical Review(s)
`Part 1 (PDF)
`Part 2 (PDF)
`Part 3 (PDF)
`Part 4 (PDF)
`Part 5 (PDF)
`• Chemistry Review(s) (PDF)
`• Pharmacology Review(s)
`Part 1 (PDF)
`Part 2 (PDF)
`Part 3 (PDF)
`Part 4 (PDF)
`Part 5 (PDF)
`• Statistical Review(s) (PDF)
`• Clinical Pharmacology Biopharmaceutics Review(s)
`Part 1 (PDF)
`Part 2 (PDF)
`Part 3 (PDF)
`• Administrative Document(s)
`Part 1 (PDF)
`Part 2 (PDF)
`• Correspondence (PDF)
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`Date created: March 07, 2003
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`http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-411_Strattera.cfm
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`2/23/2016
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`Roxane Labs., Inc.
`Exhibit 1020
`Page 001
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`
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`Drug Approval Package: Strattera (Atomoxetine Hydrochloride) NDA #21-411
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`http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-411_Strattera.cfm
`
`2/23/2016
`
`Roxane Labs., Inc.
`Exhibit 1020
`Page 002