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Last Updated: January 20, 2020

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Sigma-1 Agonist Drug Class List

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Drugs in Drug Class: Sigma-1 Agonist

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Wockhardt Bio Ag PROMETHAZINE W/ DEXTROMETHORPHAN dextromethorphan hydrobromide; promethazine hydrochloride SYRUP;ORAL 088864-001 Jan 4, 1985 AA RX No No   Start Trial   Start Trial   Start Trial
Amneal Pharms PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE dextromethorphan hydrobromide; promethazine hydrochloride SYRUP;ORAL 090575-001 Feb 8, 2011 DISCN No No   Start Trial   Start Trial   Start Trial
Hi Tech Pharma PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE dextromethorphan hydrobromide; promethazine hydrochloride SYRUP;ORAL 040027-001 Jul 31, 1996 AA RX No No   Start Trial   Start Trial   Start Trial
Vintage PROMETHAZINE DM dextromethorphan hydrobromide; promethazine hydrochloride SYRUP;ORAL 040649-001 Feb 14, 2006 DISCN No No   Start Trial   Start Trial   Start Trial
Avanir Pharms NUEDEXTA dextromethorphan hydrobromide; quinidine sulfate CAPSULE;ORAL 021879-001 Oct 29, 2010 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Avanir Pharms NUEDEXTA dextromethorphan hydrobromide; quinidine sulfate CAPSULE;ORAL 021879-001 Oct 29, 2010 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Vintage Pharms BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride SYRUP;ORAL 202940-001 Jul 21, 2014 DISCN 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:

Express Scripts
Merck
Mallinckrodt
Medtronic
Boehringer Ingelheim
Colorcon

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