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Last Updated: November 7, 2024

Details for New Drug Application (NDA): 022063


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NDA 022063 describes MYDAYIS, which is a drug marketed by Takeda Pharms Usa and is included in one NDA. It is available from one supplier. There are two patents protecting this drug and two Paragraph IV challenges. Additional details are available on the MYDAYIS profile page.

The generic ingredient in MYDAYIS is amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate. There are fifty-five drug master file entries for this compound. Twenty-eight 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: 022063
Suppliers and Packaging for NDA: 022063
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MYDAYIS amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 022063 NDA Takeda Pharmaceuticals America, Inc. 54092-468 54092-468-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54092-468-01)
MYDAYIS amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 022063 NDA Takeda Pharmaceuticals America, Inc. 54092-471 54092-471-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54092-471-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength3.125MG;3.125MG;3.125MG;3.125MG
Approval Date:Jun 20, 2017TE:AB2RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Aug 24, 2029Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:May 12, 2026Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength6.25MG;6.25MG;6.25MG;6.25MG
Approval Date:Jun 20, 2017TE:AB2RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Aug 24, 2029Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 022063

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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 verification 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.