An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 076421
Company: SUN PHARM INDS LTD

Products on ANDA 076421

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLECAINIDE ACETATE	FLECAINIDE ACETATE	50MG	TABLET;ORAL	Prescription	AB	No	No
FLECAINIDE ACETATE	FLECAINIDE ACETATE	100MG	TABLET;ORAL	Prescription	AB	No	No
FLECAINIDE ACETATE	FLECAINIDE ACETATE	150MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076421

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/28/2003	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 076421

FLECAINIDE ACETATE

TABLET;ORAL; 50MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FLECAINIDE ACETATE	FLECAINIDE ACETATE	50MG	TABLET;ORAL	Prescription	No	AB	075442	AMNEAL PHARM
FLECAINIDE ACETATE	FLECAINIDE ACETATE	50MG	TABLET;ORAL	Prescription	No	AB	075882	ANI PHARMS
FLECAINIDE ACETATE	FLECAINIDE ACETATE	50MG	TABLET;ORAL	Prescription	No	AB	202821	AUROBINDO PHARMA LTD
FLECAINIDE ACETATE	FLECAINIDE ACETATE	50MG	TABLET;ORAL	Prescription	No	AB	076278	HIKMA
FLECAINIDE ACETATE	FLECAINIDE ACETATE	50MG	TABLET;ORAL	Prescription	No	AB	218093	OMSAV PHARMA
FLECAINIDE ACETATE	FLECAINIDE ACETATE	50MG	TABLET;ORAL	Prescription	No	AB	210683	REGCON HOLDINGS
FLECAINIDE ACETATE	FLECAINIDE ACETATE	50MG	TABLET;ORAL	Prescription	No	AB	076421	SUN PHARM INDS LTD
FLECAINIDE ACETATE	FLECAINIDE ACETATE	50MG	TABLET;ORAL	Prescription	No	AB	215599	YICHANG HUMANWELL

TABLET;ORAL; 100MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FLECAINIDE ACETATE	FLECAINIDE ACETATE	100MG	TABLET;ORAL	Prescription	No	AB	075442	AMNEAL PHARM
FLECAINIDE ACETATE	FLECAINIDE ACETATE	100MG	TABLET;ORAL	Prescription	No	AB	075882	ANI PHARMS
FLECAINIDE ACETATE	FLECAINIDE ACETATE	100MG	TABLET;ORAL	Prescription	No	AB	202821	AUROBINDO PHARMA LTD
FLECAINIDE ACETATE	FLECAINIDE ACETATE	100MG	TABLET;ORAL	Prescription	No	AB	076278	HIKMA
FLECAINIDE ACETATE	FLECAINIDE ACETATE	100MG	TABLET;ORAL	Prescription	No	AB	218093	OMSAV PHARMA
FLECAINIDE ACETATE	FLECAINIDE ACETATE	100MG	TABLET;ORAL	Prescription	No	AB	210683	REGCON HOLDINGS
FLECAINIDE ACETATE	FLECAINIDE ACETATE	100MG	TABLET;ORAL	Prescription	No	AB	076421	SUN PHARM INDS LTD
FLECAINIDE ACETATE	FLECAINIDE ACETATE	100MG	TABLET;ORAL	Prescription	No	AB	215599	YICHANG HUMANWELL

TABLET;ORAL; 150MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FLECAINIDE ACETATE	FLECAINIDE ACETATE	150MG	TABLET;ORAL	Prescription	No	AB	075442	AMNEAL PHARM
FLECAINIDE ACETATE	FLECAINIDE ACETATE	150MG	TABLET;ORAL	Prescription	No	AB	075882	ANI PHARMS
FLECAINIDE ACETATE	FLECAINIDE ACETATE	150MG	TABLET;ORAL	Prescription	No	AB	202821	AUROBINDO PHARMA LTD
FLECAINIDE ACETATE	FLECAINIDE ACETATE	150MG	TABLET;ORAL	Prescription	No	AB	076278	HIKMA
FLECAINIDE ACETATE	FLECAINIDE ACETATE	150MG	TABLET;ORAL	Prescription	No	AB	218093	OMSAV PHARMA
FLECAINIDE ACETATE	FLECAINIDE ACETATE	150MG	TABLET;ORAL	Prescription	No	AB	210683	REGCON HOLDINGS
FLECAINIDE ACETATE	FLECAINIDE ACETATE	150MG	TABLET;ORAL	Prescription	No	AB	076421	SUN PHARM INDS LTD
FLECAINIDE ACETATE	FLECAINIDE ACETATE	150MG	TABLET;ORAL	Prescription	No	AB	215599	YICHANG HUMANWELL

Top