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Details for New Drug Application (NDA): 209905
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NDA 209905 describes EVEKEO ODT, which is a drug marketed by Arbor Pharms Llc and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the EVEKEO ODT profile page.
The generic ingredient in EVEKEO ODT is amphetamine sulfate. There are fifty-five drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the amphetamine sulfate profile page.
The generic ingredient in EVEKEO ODT is amphetamine sulfate. There are fifty-five drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the amphetamine sulfate profile page.
Summary for 209905
| Tradename: | EVEKEO ODT |
| Applicant: | Arbor Pharms Llc |
| Ingredient: | amphetamine sulfate |
| Patents: | 2 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 209905
| Physiological Effect | Central Nervous System Stimulation |
Suppliers and Packaging for NDA: 209905
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EVEKEO ODT | amphetamine sulfate | TABLET, ORALLY DISINTEGRATING;ORAL | 209905 | NDA | Arbor Pharmaceuticals | 24338-031 | 24338-031-01 | 1 CASE in 1 CARTON (24338-031-01) > 1 BLISTER PACK in 1 CASE (24338-031-30) > 30 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK |
| EVEKEO ODT | amphetamine sulfate | TABLET, ORALLY DISINTEGRATING;ORAL | 209905 | NDA | Arbor Pharmaceuticals | 24338-033 | 24338-033-01 | 1 CASE in 1 CARTON (24338-033-01) > 1 BLISTER PACK in 1 CASE (24338-033-30) > 30 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 5MG | ||||
| Approval Date: | Jan 30, 2019 | TE: | RLD: | Yes | |||||
| Patent: | Start Trial | Patent Expiration: | Apr 19, 2024 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | Start Trial | Patent Expiration: | Mar 10, 2037 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 10MG | ||||
| Approval Date: | Jan 30, 2019 | TE: | RLD: | Yes | |||||
| Patent: | Start Trial | Patent Expiration: | Apr 19, 2024 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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