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Approved Drug Products containing 03978_FLUKA listed in the FDA Orange Book. Original Data : FDA Website

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01 2PROVEPHARM SAS

02 2ZYDUS LIFESCIENCES

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PharmaCompass

01

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

METHYLENE BLUE

Brand Name : PROVAYBLUE

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 50MG/10ML (5MG/ML)

Approval Date : 2016-04-08

Application Number : 204630

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

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02

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

METHYLENE BLUE

Brand Name : PROVAYBLUE

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 10MG/2ML (5MG/ML)

Approval Date : 2019-07-18

Application Number : 204630

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

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03

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

METHYLENE BLUE

Brand Name : METHYLENE BLUE

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 10MG/2ML (5MG/ML)

Approval Date : 2023-12-05

Application Number : 215636

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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04

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

METHYLENE BLUE

Brand Name : METHYLENE BLUE

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 50MG/10ML (5MG/ML)

Approval Date : 2023-12-05

Application Number : 215636

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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