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Details for New Drug Application (NDA): 200166
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NDA 200166 describes EVEKEO, which is a drug marketed by Arbor Pharms Llc and is included in two NDAs. It is available from two suppliers. There are two patents protecting this drug. Additional details are available on the EVEKEO profile page.
The generic ingredient in EVEKEO is amphetamine sulfate. There are fifty-five drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the amphetamine sulfate profile page.
The generic ingredient in EVEKEO is amphetamine sulfate. There are fifty-five drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the amphetamine sulfate profile page.
Summary for 200166
| Tradename: | EVEKEO |
| Applicant: | Arbor Pharms Llc |
| Ingredient: | amphetamine sulfate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 200166
| Physiological Effect | Central Nervous System Stimulation |
Suppliers and Packaging for NDA: 200166
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EVEKEO | amphetamine sulfate | TABLET;ORAL | 200166 | ANDA | Arbor Pharmaceuticals | 24338-022 | 24338-022-10 | 100 TABLET in 1 BOTTLE (24338-022-10) |
| EVEKEO | amphetamine sulfate | TABLET;ORAL | 200166 | ANDA | Arbor Pharmaceuticals | 24338-026 | 24338-026-10 | 100 TABLET in 1 BOTTLE (24338-026-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Aug 9, 2012 | TE: | AA | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Aug 9, 2012 | TE: | AA | RLD: | No | ||||
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