Colazal | FDA Orange Book | Approved Drug Product List | PharmaCompass.com

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Colazal
FDA Orange Book

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Sharp is a global leader in pharmaceutical packaging and clinical trial supply services.

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Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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USP reference standards; highly characterized specimens of drug substances, impurities, excipients, degradation products & more.

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Colazal

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

17 API Suppliers, 10 USDMF, 1 EU WC, 1 KDMF, 8 NDC API, 4 Listed Suppliers, $ API Reference Price

17 API Suppliers
10 USDMF
1 EU WC
1 KDMF
8 NDC API
4 Listed Suppliers
$ API Reference Price

INTERMEDIATES

1 Intermediate Suppliers

1 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

18 FDF Dossiers, 10 FDA Orange Book, 5 Europe, 2 Australia, 1 Listed Dossiers

18 FDF Dossiers
10 FDA Orange Book
5 Europe
2 Australia
1 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - 750MG, TABLET;ORAL - 1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE;ORAL - 750MG
TABLET;ORAL - 1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

10 DKSH, 2 Faran Shimi Pharmaceutical, 1 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 4 ACG Worldwide, 4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 7 BASF, 10 Corel Pharma Chem, 1 DFE Pharma, 1 Finar, 4 Gangwal Chemicals, 4 Ideal Cures Pvt Ltd, 1 Ingredion Pharma Solutions, 12 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 6 Microlex e.U, 1 Novo Excipients, 1 Pharmatrans-Sanaq, 2 Pluviaendo, 2 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 4 Roquette, 7 Seppic, 2 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 2 Sigachi Industries, 2 Silverline Chemicals, 2 The Dow Chemical Company, 1 Valens Pharmachem, 2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

45 Coating Systems & Additives, 17 Controlled & Modified Release, 13 Lubricants & Glidants, 13 Fillers, Diluents & Binders, 11 Thickeners and Stabilizers, 10 Film Formers & Plasticizers, 10 Disintegrants & Superdisintegrants, 9 Empty Capsules, 6 Granulation, 5 Emulsifying Agents, 5 Coloring Agents, 4 Topical, 4 Vegetarian Capsules, 4 Taste Masking, 4 API Stability Enhancers, 3 Direct Compression, 3 Rheology Modifiers, 3 Solubilizers, 1 Chewable & Orodispersible Aids, 1 Parenteral, 1 Surfactant & Foaming Agents

45 Coating Systems & Additives
17 Controlled & Modified Release
13 Lubricants & Glidants
13 Fillers, Diluents & Binders
11 Thickeners and Stabilizers
10 Film Formers & Plasticizers
10 Disintegrants & Superdisintegrants
9 Empty Capsules
6 Granulation
5 Emulsifying Agents
5 Coloring Agents
4 Topical
4 Vegetarian Capsules
4 Taste Masking
4 API Stability Enhancers
3 Direct Compression
3 Rheology Modifiers
3 Solubilizers
1 Chewable & Orodispersible Aids
1 Parenteral
1 Surfactant & Foaming Agents

DIGITAL CONTENT

4 News #PharmaBuzz

4 News #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 6 Regulatory FDF Prices

2 US Medicaid Prescriptions
6 Regulatory FDF Prices

MARKET PLACE

7 APIs

7 APIs

PATENTS & EXCLUSIVITIES

8 US Patents

8 US Patents

REF. STANDARDS & IMPURITIES

2 Others

2 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 49 Xls

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10 All

01 1STRIDES PHARMA

02 1APOTEX INC

03 1CARNEGIE

04 1ESJAY PHARMA

05 1HIKMA

06 1LUPIN LTD

07 1MYLAN PHARMS INC

08 2VALEANT PHARMS INTL

09 1ZYDUS LIFESCIENCES

filter Dosage Reset all filters

10 All

01 6CAPSULE;ORAL

02 4TABLET;ORAL

filter Regulatory Info Reset all filters

10 All

01 3DISCN

02 5RX

03 2Blank

filter Brand Name Reset all filters

10 All

01 8BALSALAZIDE DISODIUM

02 1COLAZAL

03 1GIAZO

filter RLD Reset all filters

10 All

01 6No

02 2Yes

03 2Blank

Axplora Balsalazide Disodium

List of Suppliers

Product Main Page

01

STRIDES PHARMA

euroPLX 88 Lisbon

Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

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Digital Content

RLD : No

TE Code :

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 :

Strides Pharma Science

Product Web Link

Digital Content

02

APOTEX INC

AACR Annual meeting

Not Confirmed

APOTEX INC

AACR Annual meeting

Not Confirmed

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Digital Content

RLD : No

TE Code : AB

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

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

VALEANT PHARMS INTL

AACR Annual meeting

Not Confirmed

VALEANT PHARMS INTL

AACR Annual meeting

Not Confirmed

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Digital Content

RLD : Yes

TE Code : AB

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

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

VALEANT PHARMS INTL

AACR Annual meeting

Not Confirmed

VALEANT PHARMS INTL

AACR Annual meeting

Not Confirmed

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Digital Content

RLD : Yes

TE Code :

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 :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

CARNEGIE

AACR Annual meeting

Not Confirmed

CARNEGIE

AACR Annual meeting

Not Confirmed

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Digital Content

RLD : No

TE Code : AB

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

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

ESJAY PHARMA

AACR Annual meeting

Not Confirmed

ESJAY PHARMA

AACR Annual meeting

Not Confirmed

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Digital Content

RLD : No

TE Code :

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 :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

HIKMA

AACR Annual meeting

Not Confirmed

HIKMA

AACR Annual meeting

Not Confirmed

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Digital Content

RLD : No

TE Code : AB

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

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

LUPIN LTD

AACR Annual meeting

Not Confirmed

LUPIN LTD

AACR Annual meeting

Not Confirmed

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Digital Content

RLD :

TE Code :

BALSALAZIDE DISODIUM

Brand Name : BALSALAZIDE DISODIUM

Dosage Form : TABLET;ORAL

Dosage Strength : 1.1GM

Approval Date :

Application Number : 206529

RX/OTC/DISCN :

RLD :

TE Code :

Product Web Link

Digital Content

Corporate PDF

09

MYLAN PHARMS INC

AACR Annual meeting

Not Confirmed

MYLAN PHARMS INC

AACR Annual meeting

Not Confirmed

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Digital Content

RLD :

TE Code :

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 :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

ZYDUS LIFESCIENCES

AACR Annual meeting

Not Confirmed

ZYDUS LIFESCIENCES

AACR Annual meeting

Not Confirmed

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Digital Content

RLD : No

TE Code : AB

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

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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