FDA APPLICATION 21590 | FDA Orange Book | Approved Drug Product List | PharmaCompass.com

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Jazz Pharmaceuticals

Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

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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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xyz-pharma-m-2025-02-24

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Gentec Pharmaceutical Group is focused on manufacturing & developing APIs/HPAPIs, Advanced Intermediates & Fine Chemicals.

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With Fermion, start the journey of your innovative API.

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xyz-pharma-m-2025-02-24

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Jazz Pharmaceuticals

VISIT THE VIRTUAL BOOTH, Contact Details

VISIT THE VIRTUAL BOOTH
Review portfolio & marketing content
CONTACT DETAILS
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EVENTS

Webinars & Exhibitions

Webinars & Exhibitions

DIGITAL CONTENT

INTERVIEW #SpeakPharma, VLOG #PharmaReel, DATA COMPILATION #PharmaFlow, 354 NEWS #PharmaBuzz

INTERVIEW #SpeakPharma
VLOG #PharmaReel
DATA COMPILATION #PharmaFlow
354 NEWS #PharmaBuzz

ACTIVE PHARMA INGREDIENTS

1 All APIs, 1 Listed APIs

1 All APIs
1 Listed APIs

DEVELOPMENTS

58 Drugs in Development

58 Drugs in Development

FINISHED DOSAGE FORMULATIONS

30 FDF Dossiers, 19 FDA Orange Book, 1 Europe, 10 Canada

30 FDF Dossiers
19 FDA Orange Book
1 Europe
10 Canada

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filter Applicant Reset all filters

6 All

01 6JAZZ

filter Dosage Reset all filters

6 All

01 6TABLET, ORALLY DISINTEGRATING;ORAL

filter Regulatory Info Reset all filters

6 All

01 6DISCN

filter Brand Name Reset all filters

6 All

01 6FAZACLO ODT

filter RLD Reset all filters

6 All

01 1No

02 5Yes

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Brand Name : FAZACLO ODT

ECR 2025

Not Confirmed

Brand Name : FAZACLO ODT

ECR 2025

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

RLD : Yes

TE Code :

Jazz Pharmaceuticals

Dosage Form : TABLET, ORALLY DISINTEGRATING;...

Proprietary Name : FAZACLO ODT

Dosage Strength : 25MG **Federal Register ...

Approval Date : 2004-02-10

Application Number : 21590

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Product
Web Link

Stock Recap
#PipelineProspector

Market
Place

02

Brand Name : FAZACLO ODT

ECR 2025

Not Confirmed

Brand Name : FAZACLO ODT

ECR 2025

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Post an Enquiry

Post an Enquiry

Digital Content

RLD : Yes

TE Code :

Jazz Pharmaceuticals

Dosage Form : TABLET, ORALLY DISINTEGRATING;...

Proprietary Name : FAZACLO ODT

Dosage Strength : 200MG **Federal Register...

Approval Date : 2010-07-09

Application Number : 21590

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Product
Web Link

Stock Recap
#PipelineProspector

Market
Place

03

Brand Name : FAZACLO ODT

ECR 2025

Not Confirmed

Brand Name : FAZACLO ODT

ECR 2025

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Post an Enquiry

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Digital Content

RLD : Yes

TE Code :

Jazz Pharmaceuticals

Dosage Form : TABLET, ORALLY DISINTEGRATING;...

Proprietary Name : FAZACLO ODT

Dosage Strength : 12.5MG **Federal Registe...

Approval Date : 2007-05-30

Application Number : 21590

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Product
Web Link

Stock Recap
#PipelineProspector

Market
Place

04

Brand Name : FAZACLO ODT

ECR 2025

Not Confirmed

Brand Name : FAZACLO ODT

ECR 2025

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Post an Enquiry

Post an Enquiry

Digital Content

RLD : Yes

TE Code :

Jazz Pharmaceuticals

Dosage Form : TABLET, ORALLY DISINTEGRATING;...

Proprietary Name : FAZACLO ODT

Dosage Strength : 100MG **Federal Register...

Approval Date : 2004-02-10

Application Number : 21590

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Product
Web Link

Stock Recap
#PipelineProspector

Market
Place

05

Brand Name : FAZACLO ODT

ECR 2025

Not Confirmed

Brand Name : FAZACLO ODT

ECR 2025

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Post an Enquiry

Post an Enquiry

Digital Content

RLD : Yes

TE Code :

Jazz Pharmaceuticals

Dosage Form : TABLET, ORALLY DISINTEGRATING;...

Proprietary Name : FAZACLO ODT

Dosage Strength : 150MG **Federal Register...

Approval Date : 2010-07-09

Application Number : 21590

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Product
Web Link

Stock Recap
#PipelineProspector

Market
Place

06

Brand Name : FAZACLO ODT

ECR 2025

Not Confirmed

Brand Name : FAZACLO ODT

ECR 2025

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Post an Enquiry

Post an Enquiry

Digital Content

RLD : No

TE Code :

Jazz Pharmaceuticals

Dosage Form : TABLET, ORALLY DISINTEGRATING;...

Proprietary Name : FAZACLO ODT

Dosage Strength : 50MG **Federal Register ...

Approval Date : 2005-06-03

Application Number : 21590

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Product
Web Link

Stock Recap
#PipelineProspector

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Place

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