01 4TRIS PHARMA INC
01 4TABLET, EXTENDED RELEASE;ORAL
01 4RX
01 1DYANAVEL XR 10
02 1DYANAVEL XR 15
03 1DYANAVEL XR 20
04 1DYANAVEL XR 5
01 4Yes
RLD : Yes
TE Code :
AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE
Dosage Form : TABLET, EXTENDED RELEASE; ORAL
Proprietary Name : DYANAVEL XR 20
Dosage Strength : 16MG;EQ 4MG BASE
Approval Date : 2021-11-04
Application Number : 210526
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE
Dosage Form : TABLET, EXTENDED RELEASE; ORAL
Proprietary Name : DYANAVEL XR 10
Dosage Strength : 8MG;EQ 2MG BASE
Approval Date : 2021-11-04
Application Number : 210526
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE
Dosage Form : TABLET, EXTENDED RELEASE; ORAL
Proprietary Name : DYANAVEL XR 15
Dosage Strength : 12MG;EQ 3MG BASE
Approval Date : 2021-11-04
Application Number : 210526
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE
Dosage Form : TABLET, EXTENDED RELEASE; ORAL
Proprietary Name : DYANAVEL XR 5
Dosage Strength : 4MG;EQ 1MG BASE
Approval Date : 2021-11-04
Application Number : 210526
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
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