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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 040660

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NDA 040660 describes PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE, which is a drug marketed by Genus Lifesciences and is included in one NDA. Additional details are available on the PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE profile page.

The generic ingredient in PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE is codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride. There are nineteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride profile page.

Summary for 040660

Tradename:	PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE
Applicant:	Genus Lifesciences
Ingredient:	codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SYRUP;ORAL			Strength	10MG/5ML;5MG/5ML;6.25MG/5ML
Approval Date:	Dec 7, 2006	TE:	AA	RLD:	No

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