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

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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

BENDAMUSTINE HYDROCHLORIDE

Brand Name : BENDAMUSTINE HYDROCHLORIDE

Dosage Form : POWDER;IV (INFUSION)

Dosage Strength : 25MG/VIAL

Approval Date : 2022-12-07

Application Number : 205376

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

Dr Reddy Company Banner

02

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Discovery on Target
Not Confirmed

BENDAMUSTINE HYDROCHLORIDE

Brand Name : BENDAMUSTINE HYDROCHLORIDE

Dosage Form : POWDER;IV (INFUSION)

Dosage Strength : 25MG/VIAL

Approval Date : 2023-02-14

Application Number : 205447

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

Breckenridge Pharmaceutical

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

BENDAMUSTINE HYDROCHLORIDE

Brand Name : BENDAMUSTINE HYDROCHLORIDE

Dosage Form : POWDER;IV (INFUSION)

Dosage Strength : 100MG/VIAL

Approval Date : 2022-12-07

Application Number : 205376

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

Dr Reddy Company Banner

04

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Discovery on Target
Not Confirmed

BENDAMUSTINE HYDROCHLORIDE

Brand Name : BENDAMUSTINE HYDROCHLORIDE

Dosage Form : POWDER;IV (INFUSION)

Dosage Strength : 100MG/VIAL

Approval Date : 2023-02-14

Application Number : 205447

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

Breckenridge Pharmaceutical

05

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

BENDAMUSTINE HYDROCHLORIDE

Brand Name : TREANDA

Dosage Form : POWDER;IV (INFUSION)

Dosage Strength : 100MG/VIAL

Approval Date : 2008-03-20

Application Number : 22249

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

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06

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

BENDAMUSTINE HYDROCHLORIDE

Brand Name : TREANDA

Dosage Form : POWDER;IV (INFUSION)

Dosage Strength : 25MG/VIAL

Approval Date : 2009-05-01

Application Number : 22249

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

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07

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

BENDAMUSTINE HYDROCHLORIDE

Brand Name : TREANDA

Dosage Form : SOLUTION;IV (INFUSION)

Dosage Strength : 45MG/0.5ML (90MG/ML)

Approval Date : 2013-09-13

Application Number : 22249

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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08

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

BENDAMUSTINE HYDROCHLORIDE

Brand Name : TREANDA

Dosage Form : SOLUTION;IV (INFUSION)

Dosage Strength : 180MG/2ML (90MG/ML)

Approval Date : 2013-09-13

Application Number : 22249

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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09

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

BENDAMUSTINE HYDROCHLORIDE

Brand Name : TREANDA

Dosage Form : INJECTABLE; INJECTION

Dosage Strength : 100MG

Approval Date :

Application Number : 22303

RX/OTC/DISCN :

RLD :

TE Code :

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10

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

BENDAMUSTINE HYDROCHLORIDE

Brand Name : BENDAMUSTINE HYDROCHLORIDE

Dosage Form : POWDER;IV (INFUSION)

Dosage Strength : 25MG/VIAL

Approval Date :

Application Number : 204086

RX/OTC/DISCN :

RLD :

TE Code :

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