Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 218426
Company: HETERO LABS LTD III

Products on ANDA 218426

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE	DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE	20MG;10MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 218426

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/28/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 218426

DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE

CAPSULE;ORAL; 20MG;10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE	DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE	20MG;10MG	CAPSULE;ORAL	Prescription	No	AB	202934	ACTAVIS ELIZABETH
DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE	DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE	20MG;10MG	CAPSULE;ORAL	Prescription	No	AB	218426	HETERO LABS LTD III
DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE	DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE	20MG;10MG	CAPSULE;ORAL	Prescription	No	AB	204196	SUN PHARM
NUEDEXTA	DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE	20MG;10MG	CAPSULE;ORAL	Prescription	Yes	AB	021879	OTSUKA AMERICA PHARM