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Generated: December 19, 2018

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Details for New Drug Application (NDA): 017078

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NDA 017078 describes DEXEDRINE, which is a drug marketed by Impax Labs Inc and Glaxosmithkline and is included in three NDAs. It is available from four suppliers. Additional details are available on the DEXEDRINE profile page.

The generic ingredient in DEXEDRINE is dextroamphetamine sulfate. There are eighteen drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the dextroamphetamine sulfate profile page.
Summary for 017078
Tradename:DEXEDRINE
Applicant:Impax Labs Inc
Ingredient:dextroamphetamine sulfate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 017078
Medical Subject Heading (MeSH) Categories for 017078
Suppliers and Packaging for NDA: 017078
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXEDRINE dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 017078 NDA AUTHORIZED GENERIC Impax Generics 0115-1702 0115-1702-10 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1702-10)
DEXEDRINE dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 017078 NDA AUTHORIZED GENERIC Impax Generics 0115-1703 0115-1703-10 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1703-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength5MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength10MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength15MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

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