Details for New Drug Application (NDA): 022063
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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.
Summary for 022063
Tradename: | MYDAYIS |
Applicant: | Takeda Pharms Usa |
Ingredient: | amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate |
Patents: | 2 |
Pharmacology for NDA: 022063
Physiological Effect | Central Nervous System Stimulation |
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: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 3.125MG;3.125MG;3.125MG;3.125MG | ||||
Approval Date: | Jun 20, 2017 | TE: | AB2 | RLD: | Yes | ||||
Patent: | ⤷ Sign Up | Patent Expiration: | Aug 24, 2029 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | May 12, 2026 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 6.25MG;6.25MG;6.25MG;6.25MG | ||||
Approval Date: | Jun 20, 2017 | TE: | AB2 | RLD: | Yes | ||||
Patent: | ⤷ Sign Up | Patent Expiration: | Aug 24, 2029 | Product Flag? | Y | Substance Flag? | Delist Request? |
Expired US Patents for NDA 022063
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