Codeine phosphate; promethazine hydrochloride - Generic Drug Details

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What are the generic sources for codeine phosphate; promethazine hydrochloride and what is the scope of freedom to operate?

Codeine phosphate; promethazine hydrochloride is the generic ingredient in five branded drugs marketed by Ani Pharms, Halsey, Actavis Mid Atlantic, Amneal Pharms, Hikma, Nostrum Labs Inc, Pharm Assoc, Quagen, Tris Pharma Inc, Wockhardt Bio Ag, and Cenci, and is included in twelve NDAs. Additional information is available in the individual branded drug profile pages.

Six 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 CODEINE PHOSPHATE	codeine phosphate; promethazine hydrochloride	SYRUP;ORAL	200386-001	Jun 29, 2012	AA	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Cenci	PROMETHAZINE W/ CODEINE	codeine phosphate; promethazine hydrochloride	SYRUP;ORAL	088814-001	Nov 22, 1985		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Quagen	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	codeine phosphate; promethazine hydrochloride	SYRUP;ORAL	214238-001	Oct 8, 2020	AA	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Halsey	PHERAZINE W/ CODEINE	codeine phosphate; promethazine hydrochloride	SYRUP;ORAL	088739-001	Dec 23, 1988		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Nostrum Labs Inc	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	codeine phosphate; promethazine hydrochloride	SYRUP;ORAL	090180-001	Mar 17, 2010	AA	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pharm Assoc	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	codeine phosphate; promethazine hydrochloride	SYRUP;ORAL	089647-001	Dec 22, 1988		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:	11
NDAs:	12
Finished Product Suppliers / Packagers:	6
DailyMed Link:	codeine phosphate; promethazine hydrochloride at DailyMed

Drug Class	Opioid Agonist Phenothiazine
Mechanism of Action	Full Opioid Agonists