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Approved Drug Products containing 203496 listed in the FDA Orange Book. Original Data : FDA Website

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01

Brand Name : ORENITRAM

AAPS 2024
Not Confirmed
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Brand Name : ORENITRAM

AAPS 2024
Not Confirmed
arrow

United Therapeutics

Dosage Form : TABLET, EXTENDED RELEASE; ORAL

Proprietary Name : ORENITRAM

Dosage Strength : EQ 0.25MG BASE

Approval Date : 2013-12-20

Application Number : 203496

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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02

Brand Name : ORENITRAM

AAPS 2024
Not Confirmed
arrow

Brand Name : ORENITRAM

AAPS 2024
Not Confirmed
arrow

United Therapeutics

Dosage Form : TABLET, EXTENDED RELEASE; ORAL

Proprietary Name : ORENITRAM

Dosage Strength : EQ 5MG BASE

Approval Date : 2016-10-07

Application Number : 203496

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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03

Brand Name : ORENITRAM

AAPS 2024
Not Confirmed
arrow

Brand Name : ORENITRAM

AAPS 2024
Not Confirmed
arrow

United Therapeutics

Dosage Form : TABLET, EXTENDED RELEASE; ORAL

Proprietary Name : ORENITRAM

Dosage Strength : EQ 1MG BASE

Approval Date : 2013-12-20

Application Number : 203496

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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04

Brand Name : ORENITRAM

AAPS 2024
Not Confirmed
arrow

Brand Name : ORENITRAM

AAPS 2024
Not Confirmed
arrow

United Therapeutics

Dosage Form : TABLET, EXTENDED RELEASE; ORAL

Proprietary Name : ORENITRAM

Dosage Strength : EQ 0.125MG BASE

Approval Date : 2013-12-20

Application Number : 203496

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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05

Brand Name : ORENITRAM

AAPS 2024
Not Confirmed
arrow

Brand Name : ORENITRAM

AAPS 2024
Not Confirmed
arrow

United Therapeutics

Dosage Form : TABLET, EXTENDED RELEASE; ORAL

Proprietary Name : ORENITRAM

Dosage Strength : EQ 2.5MG BASE

Approval Date : 2013-12-20

Application Number : 203496

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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