Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202934
Company: ACTAVIS ELIZABETH

Products on ANDA 202934

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 202934

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/10/2017	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202934Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/24/2023	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 202934

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