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

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01 1DR REDDYS

02 2GLAND PHARMA LTD

03 2HIKMA

04 1LONG GROVE PHARMS

05 3MITSUBISHI TANABE

06 1ZYDUS PHARMS USA INC

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  • 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

EDARAVONE

Brand Name : EDARAVONE

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 60MG/100ML (0.6MG/ML)

Approval Date : 2024-05-06

Application Number : 215917

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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EDARAVONE

Brand Name : EDARAVONE

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 30MG/100ML (0.3MG/ML)

Approval Date : 2024-05-06

Application Number : 216199

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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EDARAVONE

Brand Name : EDARAVONE

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 60MG/100ML (0.6MG/ML)

Approval Date : 2024-05-06

Application Number : 216199

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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EDARAVONE

Brand Name : EDARAVONE

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 30MG/100ML (0.3MG/ML)

Approval Date : 2024-05-06

Application Number : 215508

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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EDARAVONE

Brand Name : EDARAVONE

Dosage Form : INJECTION;SOLUTION

Dosage Strength : 60mg/100mL

Approval Date :

Application Number : 215508

RX/OTC/DISCN :

RLD :

TE Code :

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EDARAVONE

Brand Name : EDARAVONE

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 30MG/100ML (0.3MG/ML)

Approval Date : 2024-05-06

Application Number : 218354

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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EDARAVONE

Brand Name : RADICAVA

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 30MG/100ML (0.3MG/ML)

Approval Date : 2017-05-05

Application Number : 209176

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

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EDARAVONE

Brand Name : RADICAVA

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 60MG/100ML (0.6MG/ML)

Approval Date : 2018-11-15

Application Number : 209176

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

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EDARAVONE

Brand Name : RADICAVA ORS

Dosage Form : SUSPENSION;ORAL

Dosage Strength : 105MG/5ML

Approval Date : 2022-05-12

Application Number : 215446

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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EDARAVONE

Brand Name : EDARAVONE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 30MG/100ML(0.3MG/ML)

Approval Date :

Application Number : 218349

RX/OTC/DISCN :

RLD :

TE Code :

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