Details for New Drug Application (NDA): 200166
NDA 200166 describes EVEKEO, which is a drug marketed by Azurity and is included in two NDAs. It is available from three suppliers. There are three patents protecting this drug. Additional details are available on the EVEKEO profile page.
The generic ingredient in EVEKEO is amphetamine sulfate. There is one drug master file entry for this compound. Twelve 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 is one drug master file entry for this compound. Twelve suppliers are listed for this compound. Additional details are available on the amphetamine sulfate profile page.
Summary for 200166
| Tradename: | EVEKEO |
| Applicant: | Azurity |
| Ingredient: | amphetamine sulfate |
| Patents: | 0 |
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 | Azurity Pharmaceuticals, Inc. | 24338-022 | 24338-022-03 | 30 TABLET in 1 BOTTLE (24338-022-03) |
| EVEKEO | amphetamine sulfate | TABLET;ORAL | 200166 | ANDA | Azurity Pharmaceuticals, Inc. | 24338-026 | 24338-026-03 | 30 TABLET in 1 BOTTLE (24338-026-03) |
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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