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

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01 2STRIDES PHARMA

02 2ANNORA PHARMA

03 2AUROBINDO PHARMA

04 2DR REDDYS LABS LTD

05 2RISING PHARMS

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

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

RLD : Yes

TE Code : AB

ZAFIRLUKAST

Brand Name : ACCOLATE

Dosage Form : TABLET;ORAL

Dosage Strength : 20MG

Approval Date : 1996-09-26

Application Number : 20547

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

Strides Pharma Science

02

  • fda
  • EDQM
  • WHO-GMP

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

RLD : Yes

TE Code : AB

ZAFIRLUKAST

Brand Name : ACCOLATE

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Approval Date : 1999-09-17

Application Number : 20547

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

Strides Pharma Science

03

Luxepack
Not Confirmed
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Not Confirmed

ZAFIRLUKAST

Brand Name : ZAFIRLUKAST

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Approval Date : 2020-09-10

Application Number : 212475

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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04

Luxepack
Not Confirmed
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Luxepack
Not Confirmed

ZAFIRLUKAST

Brand Name : ZAFIRLUKAST

Dosage Form : TABLET;ORAL

Dosage Strength : 20MG

Approval Date : 2020-09-10

Application Number : 212475

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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05

Luxepack
Not Confirmed
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Luxepack
Not Confirmed

ZAFIRLUKAST

Brand Name : ZAFIRLUKAST

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Approval Date : 2023-11-27

Application Number : 213163

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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06

Luxepack
Not Confirmed
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Luxepack
Not Confirmed

ZAFIRLUKAST

Brand Name : ZAFIRLUKAST

Dosage Form : TABLET;ORAL

Dosage Strength : 20MG

Approval Date : 2023-11-27

Application Number : 213163

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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07

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Not Confirmed
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Not Confirmed

ZAFIRLUKAST

Brand Name : ZAFIRLUKAST

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Approval Date : 2022-08-25

Application Number : 204928

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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08

Luxepack
Not Confirmed
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Not Confirmed

ZAFIRLUKAST

Brand Name : ZAFIRLUKAST

Dosage Form : TABLET;ORAL

Dosage Strength : 20MG

Approval Date : 2022-08-25

Application Number : 204928

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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09

DR REDDYS LABS LTD

Luxepack
Not Confirmed
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DR REDDYS LABS LTD

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Luxepack
Not Confirmed

ZAFIRLUKAST

Brand Name : ZAFIRLUKAST

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Approval Date : 2010-11-18

Application Number : 90372

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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10

DR REDDYS LABS LTD

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Not Confirmed
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DR REDDYS LABS LTD

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Luxepack
Not Confirmed

ZAFIRLUKAST

Brand Name : ZAFIRLUKAST

Dosage Form : TABLET;ORAL

Dosage Strength : 20MG

Approval Date : 2010-11-18

Application Number : 90372

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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