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Details for New Drug Application (NDA): 209905
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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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