Details for New Drug Application (NDA): 210526
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The generic ingredient in DYANAVEL XR 5 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 210526
Tradename: | DYANAVEL XR 5 |
Applicant: | Tris Pharma Inc |
Ingredient: | amphetamine; amphetamine aspartate/dextroamphetamine sulfate |
Patents: | 4 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 210526
Generic Entry Date for 210526*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET, 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: 210526
Physiological Effect | Central Nervous System Stimulation |
Suppliers and Packaging for NDA: 210526
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DYANAVEL XR 10 | amphetamine; amphetamine aspartate/dextroamphetamine sulfate | TABLET, EXTENDED RELEASE;ORAL | 210526 | NDA | NextWave Pharmaceuticals, Inc | 24478-106 | 24478-106-01 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (24478-106-01) |
DYANAVEL XR 15 | amphetamine; amphetamine aspartate/dextroamphetamine sulfate | TABLET, EXTENDED RELEASE;ORAL | 210526 | NDA | NextWave Pharmaceuticals, Inc | 24478-106 | 24478-106-01 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (24478-106-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 4MG;EQ 1MG BASE | ||||
Approval Date: | Nov 4, 2021 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Sep 24, 2038 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Mar 15, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Mar 15, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? |
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