Last Updated: May 6, 2026

Code - Generic Drug Details

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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
Lannett Co Inc	CODEINE SULFATE	codeine sulfate	TABLET;ORAL	203046-001	Jun 13, 2014	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Hikma	CODEINE SULFATE	codeine sulfate	TABLET;ORAL	022402-001	Jul 16, 2009	AB	RX	Yes	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Wockhardt	PROMETHAZINE VC W/ CODEINE	codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride	SYRUP;ORAL	088896-001	Jan 4, 1985		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Chartwell Rx	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	codeine phosphate; promethazine hydrochloride	SYRUP;ORAL	090180-001	Mar 17, 2010	AA	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Hikma	CODEINE SULFATE	codeine sulfate	TABLET;ORAL	022402-003	Jul 16, 2009	AB	RX	Yes	Yes	⤷ 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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