Details for New Drug Application (NDA): 208147
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The generic ingredient in DYANAVEL XR is amphetamine; amphetamine aspartate/dextroamphetamine sulfate. There are fifty-five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the amphetamine; amphetamine aspartate/dextroamphetamine sulfate profile page.
Summary for 208147
Tradename: | DYANAVEL XR |
Applicant: | Tris Pharma Inc |
Ingredient: | amphetamine; amphetamine aspartate/dextroamphetamine sulfate |
Patents: | 7 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 208147
Generic Entry Date for 208147*:
Constraining patent/regulatory exclusivity:
Dosage:
SUSPENSION, EXTENDED RELEASE;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 208147
Physiological Effect | Central Nervous System Stimulation |
Suppliers and Packaging for NDA: 208147
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DYANAVEL XR | amphetamine; amphetamine aspartate/dextroamphetamine sulfate | SUSPENSION, EXTENDED RELEASE;ORAL | 208147 | NDA | NextWave Pharmaceuticals, Inc | 24478-102 | 24478-102-01 | 1 BOTTLE in 1 CARTON (24478-102-01) / 464 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION, EXTENDED RELEASE;ORAL | Strength | 2MG/ML;EQ 0.5MG BASE/ML | ||||
Approval Date: | Oct 19, 2015 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Mar 15, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Sep 7, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Mar 29, 2029 | Product Flag? | Y | Substance Flag? | Delist Request? |
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