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.
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: | 8,846,100 | Patent Expiration: | Aug 24, 2029 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 9,173,857 | 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: | 8,846,100 | Patent Expiration: | Aug 24, 2029 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 022063
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Takeda Pharms Usa | MYDAYIS | amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate | CAPSULE, EXTENDED RELEASE;ORAL | 022063-003 | Jun 20, 2017 | RE41148 | ⤷ Subscribe |
| Takeda Pharms Usa | MYDAYIS | amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate | CAPSULE, EXTENDED RELEASE;ORAL | 022063-002 | Jun 20, 2017 | RE42096 | ⤷ Subscribe |
| Takeda Pharms Usa | MYDAYIS | amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate | CAPSULE, EXTENDED RELEASE;ORAL | 022063-001 | Jun 20, 2017 | 6,913,768 | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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