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Last Updated: February 27, 2021

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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 Takeda Pharms Usa and is included in one NDA. It is available from four suppliers. 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-five drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate profile page.
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 Sandoz Inc 0781-2329 0781-2329-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0781-2329-01)
ADDERALL XR 10 amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 021303 NDA AUTHORIZED GENERIC Sandoz Inc 0781-2335 0781-2335-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0781-2335-01)

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

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength5MG;5MG;5MG;5MG
Approval Date:Oct 11, 2001TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength7.5MG;7.5MG;7.5MG;7.5MG
Approval Date:Oct 11, 2001TE:ABRLD:Yes

Expired US Patents for NDA 021303

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Serving leading biopharmaceutical companies globally:

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