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AstraZeneca
Citi
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Deloitte
Dow
Johnson and Johnson
Julphar
Chubb
Federal Trade Commission

Generated: June 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021303

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NDA 021303 describes ADDERALL XR 5, which is a drug marketed by Shire and is included in one NDA. It is available from six suppliers. There are four patents protecting this drug. Additional details are available on the ADDERALL XR 5 profile page.

The generic ingredient in ADDERALL XR 5 is amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate. There are fifty-four drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate profile page.
Summary for 021303
Pharmacology for NDA: 021303
Suppliers and Packaging for NDA: 021303
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ADDERALL XR 10 amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 021303 NDA AUTHORIZED GENERIC Global Pharmaceuticals, Division of Impax Laboratories Inc. 0115-1328 N 0115-1328-01
ADDERALL XR 10 amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 021303 NDA AUTHORIZED GENERIC Global Pharmaceuticals, Division of Impax Laboratories Inc. 0115-1329 N 0115-1329-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength2.5MG;2.5MG;2.5MG;2.5MG
Approval Date:Oct 11, 2001TE:ABRLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Apr 21, 2019Product Flag?Substance Flag?Delist Request?Y
Patent:➤ Try a Free TrialPatent Expiration:Apr 21, 2019Product Flag?Substance Flag?Delist Request?Y
Patent:➤ Try a Free TrialPatent Expiration:Apr 21, 2019Product Flag?Substance Flag?Delist Request?Y

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Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
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Express Scripts
Harvard Business School
Federal Trade Commission
Accenture
Covington
Daiichi Sankyo
McKinsey

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