Last Updated: May 10, 2026

Details for New Drug Application (NDA): 218264

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NDA 218264 describes PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE, which is a drug marketed by Amneal Pharms, Ani Pharms, Cosette, Hetero Labs Ltd Iii, and Hikma, and is included in five NDAs. It is available from seven suppliers. Additional details are available on the PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE profile page.

The generic ingredient in PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE is dextromethorphan hydrobromide; promethazine hydrochloride. There are twenty-three drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the dextromethorphan hydrobromide; promethazine hydrochloride profile page.

Summary for 218264

Tradename:	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
Applicant:	Hetero Labs Ltd Iii
Ingredient:	dextromethorphan hydrobromide; promethazine hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SYRUP;ORAL			Strength	15MG/5ML;6.25MG/5ML
Approval Date:	Mar 12, 2026	TE:	AA	RLD:	No

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