DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE - Generic Drug Details

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What are the generic sources for dextromethorphan hydrobromide; promethazine hydrochloride and what is the scope of patent protection?

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

Eleven suppliers are listed for this compound.

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Tris Pharma Inc	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	dextromethorphan hydrobromide; promethazine hydrochloride	SYRUP;ORAL	091687-001	Jun 28, 2012	AA	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Halsey	PHERAZINE DM	dextromethorphan hydrobromide; promethazine hydrochloride	SYRUP;ORAL	088913-001	Mar 2, 1987		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ani Pharms	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	dextromethorphan hydrobromide; promethazine hydrochloride	SYRUP;ORAL	011265-002	Apr 2, 1984	AA	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Amneal Pharms	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	dextromethorphan hydrobromide; promethazine hydrochloride	SYRUP;ORAL	090575-001	Feb 8, 2011	AA	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Slate Run Pharma	PROMETHAZINE DM	dextromethorphan hydrobromide; promethazine hydrochloride	SYRUP;ORAL	040649-001	Feb 14, 2006	AA	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
G And W Labs Inc	PROMETH W/ DEXTROMETHORPHAN	dextromethorphan hydrobromide; promethazine hydrochloride	SYRUP;ORAL	088762-001	Oct 31, 1984		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

US Patents:	0
Tradenames:	5
Applicants:	8
NDAs:	8
Finished Product Suppliers / Packagers:	11
DailyMed Link:	DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE at DailyMed

Drug Class	Phenothiazine Sigma-1 Agonist Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Mechanism of Action	Sigma-1 Receptor Agonists Uncompetitive NMDA Receptor Antagonists