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01 7AMPHETAMINE
02 1CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX
03 4METHYLPHENIDATE
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01 2SUSPENSION, EXTENDED RELEASE;ORAL
02 10TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL
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01 117.3MG
02 125.9MG
03 134.6MG
04 18.6MG
05 1EQ 1.25MG BASE/ML
06 1EQ 12.5MG BASE
07 1EQ 15.7MG BASE
08 1EQ 18.8MG BASE
09 1EQ 3.1MG BASE
10 1EQ 6.3MG BASE
11 1EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML
12 1EQ 9.4MG BASE
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01 3DISCN
02 9RX
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RLD : Yes
TE Code :
Dosage Form : SUSPENSION, EXTENDED RELEASE; ...
Proprietary Name : ADZENYS ER
Dosage Strength : EQ 1.25MG BASE/ML
Approval Date : 2017-09-15
Application Number : 204325
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :

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RLD : Yes
TE Code : AB
Dosage Form : TABLET, ORALLY DISINTEGRATING,...
Proprietary Name : ADZENYS XR-ODT
Dosage Strength : EQ 3.1MG BASE
Approval Date : 2016-01-27
Application Number : 204326
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AB

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RLD : Yes
TE Code : AB
Dosage Form : TABLET, ORALLY DISINTEGRATING,...
Proprietary Name : ADZENYS XR-ODT
Dosage Strength : EQ 6.3MG BASE
Approval Date : 2016-01-27
Application Number : 204326
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AB

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RLD : Yes
TE Code : AB
Dosage Form : TABLET, ORALLY DISINTEGRATING,...
Proprietary Name : ADZENYS XR-ODT
Dosage Strength : EQ 9.4MG BASE
Approval Date : 2016-01-27
Application Number : 204326
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AB

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RLD : Yes
TE Code : AB
Dosage Form : TABLET, ORALLY DISINTEGRATING,...
Proprietary Name : ADZENYS XR-ODT
Dosage Strength : EQ 12.5MG BASE
Approval Date : 2016-01-27
Application Number : 204326
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AB

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RLD : Yes
TE Code : AB
Dosage Form : TABLET, ORALLY DISINTEGRATING,...
Proprietary Name : ADZENYS XR-ODT
Dosage Strength : EQ 15.7MG BASE
Approval Date : 2016-01-27
Application Number : 204326
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AB

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RLD : Yes
TE Code : AB
Dosage Form : TABLET, ORALLY DISINTEGRATING,...
Proprietary Name : ADZENYS XR-ODT
Dosage Strength : EQ 18.8MG BASE
Approval Date : 2016-01-27
Application Number : 204326
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AB

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RLD : No
TE Code :
CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX
Dosage Form : SUSPENSION, EXTENDED RELEASE; ...
Proprietary Name : HYDROCODONE POLISTIREX A...
Dosage Strength : EQ 8MG MALEATE/5ML;EQ 10...
Approval Date : 2012-06-29
Application Number : 91671
RX/OTC/DISCN : DISCN
RLD : No
TE Code :

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RLD : Yes
TE Code :
Dosage Form : TABLET, ORALLY DISINTEGRATING,...
Proprietary Name : COTEMPLA XR-ODT
Dosage Strength : 8.6MG
Approval Date : 2017-06-19
Application Number : 205489
RX/OTC/DISCN : RX
RLD : Yes
TE Code :

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RLD : Yes
TE Code :
Dosage Form : TABLET, ORALLY DISINTEGRATING,...
Proprietary Name : COTEMPLA XR-ODT
Dosage Strength : 17.3MG
Approval Date : 2017-06-19
Application Number : 205489
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
