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Last Updated: February 20, 2026

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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
Hikma	CODEINE SULFATE	codeine sulfate	TABLET;ORAL	022402-002	Jul 16, 2009	AB	RX	Yes	No	⤷ Get Started Free	⤷ Get Started Free				⤷ Get Started Free
Cenci	PROMETHAZINE VC W/ CODEINE	codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride	SYRUP;ORAL	088816-001	Nov 22, 1985		DISCN	No	No	⤷ Get Started Free	⤷ Get Started Free				⤷ Get Started Free
Amneal Pharms	PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE	codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride	SYRUP;ORAL	200963-001	Aug 26, 2015	AA	RX	No	No	⤷ Get Started Free	⤷ Get Started Free				⤷ Get Started Free
>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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