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Generated: November 13, 2018

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Details for New Drug Application (NDA): 200166

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NDA 200166 describes EVEKEO, which is a drug marketed by Arbor Pharms Llc and is included in one NDA. It is available from two suppliers. Additional details are available on the EVEKEO profile page.

The generic ingredient in EVEKEO is amphetamine sulfate. There are fifty-four drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the amphetamine sulfate profile page.
Summary for 200166
Tradename:EVEKEO
Applicant:Arbor Pharms Llc
Ingredient:amphetamine sulfate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 200166
Suppliers and Packaging for NDA: 200166
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EVEKEO amphetamine sulfate TABLET;ORAL 200166 ANDA Arbor Pharmaceuticals 24338-022 24338-022-10 100 TABLET in 1 BOTTLE (24338-022-10)
EVEKEO amphetamine sulfate TABLET;ORAL 200166 ANDA Arbor Pharmaceuticals 24338-026 24338-026-10 100 TABLET in 1 BOTTLE (24338-026-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Aug 9, 2012TE:AARLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Aug 9, 2012TE:AARLD:No

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