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01 3ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE
02 4ARIMOCLOMOL CITRATE
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01 4CAPSULE;ORAL
02 3TABLET;ORAL
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01 1325MG;EQ 4.08MG BASE
02 1325MG;EQ 6.12MG BASE
03 1325MG;EQ 8.16MG BASE
04 1EQ 124MG BASE
05 1EQ 47MG BASE
06 1EQ 62MG BASE
07 1EQ 93MG BASE
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01 3DISCN
02 4RX
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RLD : Yes
TE Code :
ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE
Dosage Form : TABLET; ORAL
Proprietary Name : APADAZ
Dosage Strength : 325MG;EQ 6.12MG BASE
Approval Date : 2018-02-23
Application Number : 208653
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :

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RLD : Yes
TE Code :
ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE
Dosage Form : TABLET; ORAL
Proprietary Name : APADAZ
Dosage Strength : 325MG;EQ 4.08MG BASE
Approval Date : 2019-01-04
Application Number : 208653
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :

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RLD : Yes
TE Code :
ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE
Dosage Form : TABLET; ORAL
Proprietary Name : APADAZ
Dosage Strength : 325MG;EQ 8.16MG BASE
Approval Date : 2019-01-04
Application Number : 208653
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :

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RLD : Yes
TE Code :
Dosage Form : CAPSULE; ORAL
Proprietary Name : MIPLYFFA
Dosage Strength : EQ 47MG BASE
Approval Date : 2024-09-20
Application Number : 214927
RX/OTC/DISCN : RX
RLD : Yes
TE Code :

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RLD : Yes
TE Code :
Dosage Form : CAPSULE; ORAL
Proprietary Name : MIPLYFFA
Dosage Strength : EQ 62MG BASE
Approval Date : 2024-09-20
Application Number : 214927
RX/OTC/DISCN : RX
RLD : Yes
TE Code :

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RLD : Yes
TE Code :
Dosage Form : CAPSULE; ORAL
Proprietary Name : MIPLYFFA
Dosage Strength : EQ 93MG BASE
Approval Date : 2024-09-20
Application Number : 214927
RX/OTC/DISCN : RX
RLD : Yes
TE Code :

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RLD : Yes
TE Code :
Dosage Form : CAPSULE; ORAL
Proprietary Name : MIPLYFFA
Dosage Strength : EQ 124MG BASE
Approval Date : 2024-09-20
Application Number : 214927
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
