Last Updated: July 29, 2026

Details for New Drug Application (NDA): 204196

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NDA 204196 describes DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE, which is a drug marketed by Actavis Elizabeth, Hetero Labs Ltd Iii, and Sun Pharm, and is included in three NDAs. It is available from one supplier. Additional details are available on the DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE profile page.

The generic ingredient in DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE is dextromethorphan hydrobromide; quinidine sulfate. There are twenty-three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the dextromethorphan hydrobromide; quinidine sulfate profile page.

Summary for 204196

Tradename:	DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE
Applicant:	Sun Pharm
Ingredient:	dextromethorphan hydrobromide; quinidine sulfate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	20MG;10MG
Approval Date:	Jun 3, 2026	TE:	AB	RLD:	No

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