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

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01 4DR REDDYS

02 2ACTAVIS LABS

03 4ALEMBIC GLOBAL

04 4ENDO OPERATIONS

05 4SANDOZ

06 4TEVA PHARMS USA

07 17UNITED THERAP

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

RLD : No

TE Code : AP

TREPROSTINIL

Brand Name : TREPROSTINIL

Dosage Form : INJECTABLE;IV (INFUSION), SUBCUTANEOUS

Dosage Strength : 1MG/ML

Approval Date : 2020-05-22

Application Number : 210214

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

Dr Reddy Company Banner

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

RLD : No

TE Code : AP

TREPROSTINIL

Brand Name : TREPROSTINIL

Dosage Form : INJECTABLE;IV (INFUSION), SUBCUTANEOUS

Dosage Strength : 2.5MG/ML

Approval Date : 2020-05-22

Application Number : 210214

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

Dr Reddy Company Banner

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

RLD : No

TE Code : AP

TREPROSTINIL

Brand Name : TREPROSTINIL

Dosage Form : INJECTABLE;IV (INFUSION), SUBCUTANEOUS

Dosage Strength : 5MG/ML

Approval Date : 2020-05-22

Application Number : 210214

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

Dr Reddy Company Banner

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

RLD : No

TE Code : AP

TREPROSTINIL

Brand Name : TREPROSTINIL

Dosage Form : INJECTABLE;IV (INFUSION), SUBCUTANEOUS

Dosage Strength : 10MG/ML

Approval Date : 2020-05-22

Application Number : 210214

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

Dr Reddy Company Banner

05

FNCE 2024
Not Confirmed
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FNCE 2024
Not Confirmed

TREPROSTINIL

Brand Name : REMODULIN

Dosage Form : INJECTABLE;IV (INFUSION), SUBCUTANEOUS

Dosage Strength : 1MG/ML

Approval Date : 2002-05-21

Application Number : 21272

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

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06

FNCE 2024
Not Confirmed
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FNCE 2024
Not Confirmed

TREPROSTINIL

Brand Name : REMODULIN

Dosage Form : INJECTABLE;IV (INFUSION), SUBCUTANEOUS

Dosage Strength : 2.5MG/ML

Approval Date : 2002-05-21

Application Number : 21272

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

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07

FNCE 2024
Not Confirmed
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FNCE 2024
Not Confirmed

TREPROSTINIL

Brand Name : REMODULIN

Dosage Form : INJECTABLE;IV (INFUSION), SUBCUTANEOUS

Dosage Strength : 5MG/ML

Approval Date : 2002-05-21

Application Number : 21272

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

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08

FNCE 2024
Not Confirmed
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FNCE 2024
Not Confirmed

TREPROSTINIL

Brand Name : REMODULIN

Dosage Form : INJECTABLE;IV (INFUSION), SUBCUTANEOUS

Dosage Strength : 10MG/ML

Approval Date : 2002-05-21

Application Number : 21272

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

blank

09

FNCE 2024
Not Confirmed
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FNCE 2024
Not Confirmed

TREPROSTINIL

Brand Name : REMODULIN

Dosage Form : INJECTABLE;IV (INFUSION), SUBCUTANEOUS

Dosage Strength : 20MG/ML

Approval Date : 2021-07-30

Application Number : 21272

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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10

FNCE 2024
Not Confirmed
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FNCE 2024
Not Confirmed

TREPROSTINIL

Brand Name : REMODULIN

Dosage Form : INJECTABLE;IV (INFUSION), SUBCUTANEOUS

Dosage Strength : 0.1MG/ML

Approval Date : 2023-09-28

Application Number : 21272

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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