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Last Updated: September 23, 2020

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Mechanism of Action: Leukotriene Receptor Antagonists

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Drugs with Mechanism of Action: Leukotriene Receptor Antagonists

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Par Pharm Inc ACCOLATE zafirlukast TABLET;ORAL 020547-003 Sep 17, 1999 AB RX Yes No   Start Trial   Start Trial   Start Trial
Par Pharm Inc ACCOLATE zafirlukast TABLET;ORAL 020547-001 Sep 26, 1996 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Teva Pharms MONTELUKAST SODIUM montelukast sodium GRANULE;ORAL 090955-001 Aug 3, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Unichem Labs Ltd MONTELUKAST SODIUM montelukast sodium TABLET;ORAL 204290-001 Oct 8, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Torrent Pharms Ltd MONTELUKAST SODIUM montelukast sodium TABLET, CHEWABLE;ORAL 090984-002 Aug 3, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Macleods Pharms Ltd MONTELUKAST SODIUM montelukast sodium TABLET;ORAL 203366-001 Sep 11, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
Dr Reddys Labs Ltd MONTELUKAST SODIUM montelukast sodium TABLET;ORAL 201582-001 Aug 6, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Moodys
Harvard Business School
Boehringer Ingelheim
Merck
Dow

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