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01 2Biophore India Pharmaceuticals Pvt Ltd

02 2Strides Pharma Science

03 1Aizant Drug Research Solutions Pvt. Ltd.

04 1Annora Pharma

05 3CHIESI USA INC

06 1Lupin Ltd

07 1Rising Pharmaceuticals Inc

08 1Teva Pharmaceutical Industries

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

Regulatory Info :

Registration Country : India

Zileuton

Brand Name :

Dosage Form : Tablet

Dosage Strength : 600MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Biophore

02

  • fda
  • EDQM
  • WHO-GMP

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

Regulatory Info : RX

Registration Country : USA

ZILEUTON

Brand Name : ZILEUTON

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 600MG

Packaging :

Approval Date : 2019-12-16

Application Number : 212670

Regulatory Info : RX

Registration Country : USA

Strides Pharma Science

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

Regulatory Info :

Registration Country : India

Zileuton

Brand Name :

Dosage Form : Tablet

Dosage Strength : 600MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Biophore

04

  • fda
  • EDQM
  • WHO-GMP

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

Regulatory Info :

Registration Country : India

Zileuton

Brand Name :

Dosage Form : Extended-Release Tablet

Dosage Strength : 600MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Strides Pharma Science

05

American Pharma Summit
Not Confirmed
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American Pharma Summit
Not Confirmed

ZILEUTON

Brand Name : ZILEUTON

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 600MG

Packaging :

Approval Date : 2020-10-23

Application Number : 211390

Regulatory Info : RX

Registration Country : USA

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06

American Pharma Summit
Not Confirmed
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American Pharma Summit
Not Confirmed

ZILEUTON

Brand Name : ZILEUTON

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 600MG

Packaging :

Approval Date : 2022-10-11

Application Number : 215742

Regulatory Info : RX

Registration Country : USA

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07

American Pharma Summit
Not Confirmed
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American Pharma Summit
Not Confirmed

ZILEUTON

Brand Name : ZYFLO

Dosage Form : TABLET;ORAL

Dosage Strength : 300MG

Packaging :

Approval Date : 1996-12-09

Application Number : 20471

Regulatory Info : DISCN

Registration Country : USA

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08

American Pharma Summit
Not Confirmed
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American Pharma Summit
Not Confirmed

ZILEUTON

Brand Name : ZYFLO

Dosage Form : TABLET;ORAL

Dosage Strength : 600MG

Packaging :

Approval Date : 1996-12-09

Application Number : 20471

Regulatory Info : RX

Registration Country : USA

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09

American Pharma Summit
Not Confirmed
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American Pharma Summit
Not Confirmed

ZILEUTON

Brand Name : ZYFLO CR

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 2007-05-30

Application Number : 22052

Regulatory Info : DISCN

Registration Country : USA

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10

American Pharma Summit
Not Confirmed
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American Pharma Summit
Not Confirmed

ZILEUTON

Brand Name : ZILEUTON

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 600MG

Packaging :

Approval Date : 2019-11-05

Application Number : 211972

Regulatory Info : DISCN

Registration Country : USA

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11

American Pharma Summit
Not Confirmed
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American Pharma Summit
Not Confirmed

ZILEUTON

Brand Name : ZILEUTON

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 600MG

Packaging :

Approval Date : 2017-03-17

Application Number : 204929

Regulatory Info : RX

Registration Country : USA

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12

American Pharma Summit
Not Confirmed
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American Pharma Summit
Not Confirmed

ZILEUTON

Brand Name : ZILEUTON

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 600MG

Packaging :

Approval Date : 2022-05-03

Application Number : 211043

Regulatory Info : DISCN

Registration Country : USA

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