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01 2Bristol Myers Squibb

02 1Fresenius Kabi USA

03 2Teva Pharmaceutical Industries

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PharmaCompass

01

Antibody Engineering
Not Confirmed
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Antibody Engineering
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ROMIDEPSIN

Brand Name : ISTODAX

Dosage Form : POWDER;INTRAVENOUS

Dosage Strength : 10MG/VIAL

Packaging :

Approval Date : 2009-11-05

Application Number : 22393

Regulatory Info : RX

Registration Country : USA

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02

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

ROMIDEPSIN

Brand Name : ISTODAX

Dosage Form : KIT

Dosage Strength : 10MG/VIAL

Packaging : 1

Approval Date :

Application Number : 2414295

Regulatory Info : Prescription

Registration Country : Canada

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03

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

ROMIDEPSIN

Brand Name : ROMIDEPSIN

Dosage Form : POWDER;INTRAVENOUS

Dosage Strength : 10MG/VIAL

Packaging :

Approval Date : 2021-10-12

Application Number : 206254

Regulatory Info : RX

Registration Country : USA

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04

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

ROMIDEPSIN

Brand Name : ROMIDEPSIN

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 2020-03-13

Application Number : 208574

Regulatory Info : DISCN

Registration Country : USA

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05

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

ROMIDEPSIN

Brand Name : ROMIDEPSIN

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 27.5MG/5.5ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 2020-03-13

Application Number : 208574

Regulatory Info : DISCN

Registration Country : USA

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