01 6AMANTADINE HYDROCHLORIDE
02 2EPINEPHRINE
03 3OXCARBAZEPINE
04 4TOPIRAMATE
05 3VILOXAZINE HYDROCHLORIDE
01 9CAPSULE, EXTENDED RELEASE;ORAL
02 2SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS
03 7TABLET, EXTENDED RELEASE;ORAL
01 10.15MG/0.3ML (0.15MG/0.3ML)
02 10.3MG/0.3ML (0.3MG/0.3ML)
03 1100MG
04 1150MG
05 1200MG
06 125MG
07 1300MG
08 150MG
09 1600MG
10 1EQ 100MG BASE
11 1EQ 129MG BASE
12 1EQ 137MG BASE
13 1EQ 150MG BASE
14 1EQ 161MG BASE
15 1EQ 193MG BASE
16 1EQ 200MG BASE
17 1EQ 258MG BASE
18 1EQ 68.5MG BASE
01 5DISCN
02 13RX
RLD : Yes
TE Code : AB
Dosage Form : CAPSULE, EXTENDED RELEASE; ORA...
Proprietary Name : GOCOVRI
Dosage Strength : EQ 68.5MG BASE
Approval Date : 2017-08-24
Application Number : 208944
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AB
RLD : Yes
TE Code :
Dosage Form : CAPSULE, EXTENDED RELEASE; ORA...
Proprietary Name : GOCOVRI
Dosage Strength : EQ 137MG BASE
Approval Date : 2017-08-24
Application Number : 208944
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Dosage Form : TABLET, EXTENDED RELEASE; ORAL
Proprietary Name : OSMOLEX ER
Dosage Strength : EQ 129MG BASE
Approval Date : 2018-02-16
Application Number : 209410
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Dosage Form : TABLET, EXTENDED RELEASE; ORAL
Proprietary Name : OSMOLEX ER
Dosage Strength : EQ 193MG BASE
Approval Date : 2018-02-16
Application Number : 209410
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Dosage Form : TABLET, EXTENDED RELEASE; ORAL
Proprietary Name : OSMOLEX ER
Dosage Strength : EQ 258MG BASE
Approval Date : 2018-02-16
Application Number : 209410
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Dosage Form : TABLET, EXTENDED RELEASE; ORAL
Proprietary Name : OSMOLEX ER
Dosage Strength : EQ 161MG BASE
Approval Date : 2020-04-22
Application Number : 209410
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Dosage Form : SOLUTION; INTRAMUSCULAR, SUBCU...
Proprietary Name : SYMJEPI
Dosage Strength : 0.3MG/0.3ML (0.3MG/0.3ML...
Approval Date : 2017-06-15
Application Number : 207534
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Dosage Form : SOLUTION; INTRAMUSCULAR, SUBCU...
Proprietary Name : SYMJEPI
Dosage Strength : 0.15MG/0.3ML (0.15MG/0.3...
Approval Date : 2018-09-27
Application Number : 207534
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code : AB
Dosage Form : TABLET, EXTENDED RELEASE; ORAL
Proprietary Name : OXTELLAR XR
Dosage Strength : 150MG
Approval Date : 2012-10-19
Application Number : 202810
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AB
RLD : Yes
TE Code : AB
Dosage Form : TABLET, EXTENDED RELEASE; ORAL
Proprietary Name : OXTELLAR XR
Dosage Strength : 300MG
Approval Date : 2012-10-19
Application Number : 202810
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AB
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