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

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01 1ACCORD HLTHCARE INC

02 1ACTAVIS

03 1AM REGENT

04 1AMNEAL

05 1APOTEX

06 1ARTHUR GRP

07 1EUGIA PHARMA

08 1HOSPIRA

09 1MEITHEAL

10 1MYLAN INSTITUTIONAL

11 1NEXUS

12 1NORVIUM BIOSCIENCE

13 1OTSUKA PHARM

14 1PHARMASCIENCE INC

15 1PRINSTON INC

16 1SHILPA

17 1WAYLIS THERAP

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PharmaCompass

01

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

BUSULFAN

Brand Name : BUSULFAN

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 6MG/ML

Approval Date : 2017-12-08

Application Number : 205139

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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02

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

BUSULFAN

Brand Name : BUSULFAN

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 6MG/ML

Approval Date : 2015-12-22

Application Number : 202259

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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03

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

BUSULFAN

Brand Name : BUSULFAN

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 6MG/ML

Approval Date : 2018-07-31

Application Number : 205672

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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04

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

BUSULFAN

Brand Name : BUSULFAN

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 6MG/ML

Approval Date : 2019-01-14

Application Number : 207794

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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05

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

BUSULFAN

Brand Name : BUSULFEX

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 6MG/ML

Approval Date : 1999-02-04

Application Number : 20954

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

BUSULFAN

Brand Name : BUSULFAN

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 6MG/ML

Approval Date : 2017-03-24

Application Number : 207050

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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07

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

BUSULFAN

Brand Name : BUSULFAN

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 6MG/ML

Approval Date : 2017-11-20

Application Number : 208536

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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08

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

BUSULFAN

Brand Name : MYLERAN

Dosage Form : TABLET;ORAL

Dosage Strength : 2MG

Approval Date : 1982-01-01

Application Number : 9386

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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09

ARTHUR GRP

Country
Discovery on Target
Not Confirmed
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ARTHUR GRP

Country
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Discovery on Target
Not Confirmed

BUSULFAN

Brand Name : BUSULFAN

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 6MG/ML

Approval Date : 2018-09-21

Application Number : 205106

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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10

NORVIUM BIOSCIENCE

Country
Discovery on Target
Not Confirmed
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NORVIUM BIOSCIENCE

Country
arrow
Discovery on Target
Not Confirmed

BUSULFAN

Brand Name : BUSULFAN

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 6MG/ML

Approval Date : 2018-07-13

Application Number : 205184

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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