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The generic ingredient in DYANAVEL XR is amphetamine. There are fifty-four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the amphetamine profile page.
Generic Entry Opportunity Date for 208147
*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 |
Profile for product number 001
|Active Rx/OTC/Discontinued:||RX||Dosage:||SUSPENSION, EXTENDED RELEASE;ORAL||Strength||EQ 2.5MG BASE/ML|
|Approval Date:||Oct 19, 2015||TE:||RLD:||Yes|
|Regulatory Exclusivity Expiration:||Oct 19, 2018|
|Regulatory Exclusivity Use:||NEW PRODUCT|
|Patent:||➤ Sign Up||Patent Expiration:||Mar 29, 2029||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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