01 7AMPHETAMINE
02 1CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX
03 4METHYLPHENIDATE
01 6NEOS THERAPS
02 6NEOS THERAPS INC
01 2SUSPENSION, EXTENDED RELEASE;ORAL
02 10TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL
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
01 12USA
Regulatory Info : DISCN
Registration Country : USA
Dosage Form : SUSPENSION, EXTENDED REL...
Brand Name : ADZENYS ER
Dosage Strength : EQ 1.25MG BASE/ML
Packaging :
Approval Date : 2017-09-15
Application Number : 204325
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Dosage Form : TABLET, ORALLY DISINTEGR...
Brand Name : ADZENYS XR-ODT
Dosage Strength : EQ 3.1MG BASE
Packaging :
Approval Date : 2016-01-27
Application Number : 204326
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Dosage Form : TABLET, ORALLY DISINTEGR...
Brand Name : ADZENYS XR-ODT
Dosage Strength : EQ 6.3MG BASE
Packaging :
Approval Date : 2016-01-27
Application Number : 204326
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Dosage Form : TABLET, ORALLY DISINTEGR...
Brand Name : ADZENYS XR-ODT
Dosage Strength : EQ 9.4MG BASE
Packaging :
Approval Date : 2016-01-27
Application Number : 204326
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Dosage Form : TABLET, ORALLY DISINTEGR...
Brand Name : ADZENYS XR-ODT
Dosage Strength : EQ 12.5MG BASE
Packaging :
Approval Date : 2016-01-27
Application Number : 204326
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Dosage Form : TABLET, ORALLY DISINTEGR...
Brand Name : ADZENYS XR-ODT
Dosage Strength : EQ 15.7MG BASE
Packaging :
Approval Date : 2016-01-27
Application Number : 204326
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Dosage Form : TABLET, ORALLY DISINTEGR...
Brand Name : ADZENYS XR-ODT
Dosage Strength : EQ 18.8MG BASE
Packaging :
Approval Date : 2016-01-27
Application Number : 204326
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX
Dosage Form : SUSPENSION, EXTENDED REL...
Brand Name : HYDROCODONE POLISTIREX AN...
Dosage Strength : EQ 8MG MALEATE/5ML;EQ ...
Packaging :
Approval Date : 2012-06-29
Application Number : 91671
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Dosage Form : TABLET, ORALLY DISINTEGR...
Brand Name : COTEMPLA XR-ODT
Dosage Strength : 8.6MG
Packaging :
Approval Date : 2017-06-19
Application Number : 205489
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Dosage Form : TABLET, ORALLY DISINTEGR...
Brand Name : COTEMPLA XR-ODT
Dosage Strength : 34.6MG
Packaging :
Approval Date : 2024-08-19
Application Number : 205489
Regulatory Info : DISCN
Registration Country : USA
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