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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076278
Company: HIKMA

Products on ANDA 076278

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	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076278

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/14/2003	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/17/2015	SUPPL-5	Labeling		Label is not available on this site.
11/07/2007	SUPPL-3	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 076278

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	210683	BEXIMCO PHARMS USA
FLECAINIDE ACETATE	FLECAINIDE ACETATE	50MG	TABLET;ORAL	Prescription	No	AB	076278	HIKMA
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	210683	BEXIMCO PHARMS USA
FLECAINIDE ACETATE	FLECAINIDE ACETATE	100MG	TABLET;ORAL	Prescription	No	AB	076278	HIKMA
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	210683	BEXIMCO PHARMS USA
FLECAINIDE ACETATE	FLECAINIDE ACETATE	150MG	TABLET;ORAL	Prescription	No	AB	076278	HIKMA
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

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