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
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
Hikma	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	dextromethorphan hydrobromide; promethazine hydrochloride	SYRUP;ORAL	040027-001	Jul 31, 1996		DISCN	No	No	⤷ 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