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Last Updated: December 11, 2019

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Dextromethorphan hydrobromide; promethazine hydrochloride - Generic Drug Details

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What are the generic drug sources for dextromethorphan hydrobromide; promethazine hydrochloride and what is the scope of freedom to operate?

Dextromethorphan hydrobromide; promethazine hydrochloride is the generic ingredient in five branded drugs marketed by Halsey, G And W Labs Inc, Vintage, Amneal Pharms, Ani Pharms, Hi Tech Pharma, Tris Pharma Inc, and Wockhardt Bio Ag, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-three drug master file entries for dextromethorphan hydrobromide; promethazine hydrochloride. Twelve suppliers are listed for this compound.

Summary for dextromethorphan hydrobromide; promethazine hydrochloride
Pharmacology for dextromethorphan hydrobromide; promethazine hydrochloride

US Patents and Regulatory Information for dextromethorphan hydrobromide; promethazine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Halsey PHERAZINE DM dextromethorphan hydrobromide; promethazine hydrochloride SYRUP;ORAL 088913-001 Mar 2, 1987 DISCN No No   Start Trial   Start Trial   Start Trial
Tris Pharma Inc PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE dextromethorphan hydrobromide; promethazine hydrochloride SYRUP;ORAL 091687-001 Jun 28, 2012 DISCN No No   Start Trial   Start Trial   Start Trial
Ani Pharms PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE dextromethorphan hydrobromide; promethazine hydrochloride SYRUP;ORAL 011265-002 Apr 2, 1984 DISCN Yes 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
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
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
G And W Labs Inc PROMETH W/ DEXTROMETHORPHAN dextromethorphan hydrobromide; promethazine hydrochloride SYRUP;ORAL 088762-001 Oct 31, 1984 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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