Details for New Drug Application (NDA): 200166
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The generic ingredient in EVEKEO is amphetamine sulfate. There are fifty-five drug master file entries for this compound. Fourteen 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 |
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 | 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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