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01 1AARXION ANDA HLDING

02 1APOTEX

03 1HIKMA

04 1LUPIN LTD

05 1MYLAN PHARMS INC

06 1NOVITIUM PHARMA

07 1PHARMOBEDIENT

08 2VALEANT PHARMS INTL

09 1ZYDUS LIFESCIENCES

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PharmaCompass

01

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

BALSALAZIDE DISODIUM

Brand Name : BALSALAZIDE DISODIUM

Dosage Form : CAPSULE;ORAL

Dosage Strength : 750MG

Approval Date : 2007-12-28

Application Number : 77883

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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02

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

BALSALAZIDE DISODIUM

Brand Name : COLAZAL

Dosage Form : CAPSULE;ORAL

Dosage Strength : 750MG

Approval Date : 2000-07-18

Application Number : 20610

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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03

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

BALSALAZIDE DISODIUM

Brand Name : GIAZO

Dosage Form : TABLET;ORAL

Dosage Strength : 1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2012-02-03

Application Number : 22205

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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04

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

BALSALAZIDE DISODIUM

Brand Name : BALSALAZIDE DISODIUM

Dosage Form : CAPSULE;ORAL

Dosage Strength : 750MG

Approval Date : 2007-12-28

Application Number : 77806

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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06

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

BALSALAZIDE DISODIUM

Brand Name : BALSALAZIDE DISODIUM

Dosage Form : CAPSULE;ORAL

Dosage Strength : 750MG

Approval Date : 2007-12-28

Application Number : 77807

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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07

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

BALSALAZIDE DISODIUM

Brand Name : BALSALAZIDE DISODIUM

Dosage Form : TABLET;ORAL

Dosage Strength : 1.1G

Approval Date :

Application Number : 206909

RX/OTC/DISCN :

RLD :

TE Code :

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08

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

BALSALAZIDE DISODIUM

Brand Name : BALSALAZIDE DISODIUM

Dosage Form : CAPSULE;ORAL

Dosage Strength : 750MG

Approval Date : 2023-06-08

Application Number : 217592

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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09

AARXION ANDA HLDING

Country
CPhI India
Not Confirmed
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AARXION ANDA HLDING

Country
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CPhI India
Not Confirmed

BALSALAZIDE DISODIUM

Brand Name : BALSALAZIDE DISODIUM

Dosage Form : TABLET;ORAL

Dosage Strength : 1.1GM

Approval Date : 2015-09-08

Application Number : 206336

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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10

PHARMOBEDIENT

Country
CPhI India
Not Confirmed
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PHARMOBEDIENT

Country
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CPhI India
Not Confirmed

BALSALAZIDE DISODIUM

Brand Name : BALSALAZIDE DISODIUM

Dosage Form : CAPSULE;ORAL

Dosage Strength : 750MG

Approval Date : 2025-04-03

Application Number : 219422

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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