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ACTIVE SUBSTANCE / INN

AMPHETAMINE

Brand name(s): DYANAVEL XR 10, AMPHETAMINE, DYANAVEL XR, ADZENYS ER, DYANAVEL XR 15, DYANAVEL XR 5, DYANAVEL XR 20, ADZENYS XR-ODT
FDA LISTED
PRESCRIPTION
DISCONTINUED
NONE (TENTATIVE APPROVAL)
NDA204325
ANDA220284
ACTIVE SUBSTANCE
Amphetamine
REGULATORS
FDA
SPONSORS / MAH
TRIS PHARMA INC, NEOS THERAPS, NEOS THERAPS INC
TOTAL APPLICATIONS
9
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
DYANAVEL XRNDA208147TRIS PHARMA INCPrescription
AMPHETAMINEANDA209253ACTAVIS LABS FL INCPrescription
ADZENYS ERNDA204325NEOS THERAPS INCDiscontinued
AMPHETAMINEANDA220284GRANULES PHARMACEUTICALS INCNone (Tentative Approval)
ADZENYS XR-ODTNDA204326NEOS THERAPSPrescription
DYANAVEL XR 20NDA210526TRIS PHARMA INCPrescription
DYANAVEL XR 10NDA210526TRIS PHARMA INCPrescription
DYANAVEL XR 15NDA210526TRIS PHARMA INCPrescription
DYANAVEL XR 5NDA210526TRIS PHARMA INCPrescription

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