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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-two drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate profile page.

Summary for NDA: 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 0115-1328-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (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 0115-1329-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1329-01)

Summary 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:No
Patent:6,322,819*PEDPatent Expiration:Apr 21, 2019Product Flag?Substance Flag?Delist Request?Y
Patent:6,605,300*PEDPatent Expiration:Apr 21, 2019Product Flag?Substance Flag?Delist Request?Y
Patent:RE41148*PEDPatent Expiration:Apr 21, 2019Product Flag?Substance Flag?Delist Request?


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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