Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208970
Company: ZYDUS LIFESCIENCES

Products on ANDA 208970

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FELBAMATE	FELBAMATE	400MG	TABLET;ORAL	Prescription	AB	No	No
FELBAMATE	FELBAMATE	600MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 208970

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/30/2017	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 208970

FELBAMATE

TABLET;ORAL; 400MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FELBAMATE	FELBAMATE	400MG	TABLET;ORAL	Prescription	No	AB	201680	AMNEAL PHARMS
FELBAMATE	FELBAMATE	400MG	TABLET;ORAL	Prescription	No	AB	202284	ANI PHARMS
FELBAMATE	FELBAMATE	400MG	TABLET;ORAL	Prescription	No	AB	207093	TARO
FELBAMATE	FELBAMATE	400MG	TABLET;ORAL	Prescription	No	AB	208970	ZYDUS LIFESCIENCES
FELBATOL	FELBAMATE	400MG	TABLET;ORAL	Prescription	Yes	AB	020189	MYLAN SPECIALITY LP

TABLET;ORAL; 600MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FELBAMATE	FELBAMATE	600MG	TABLET;ORAL	Prescription	No	AB	201680	AMNEAL PHARMS
FELBAMATE	FELBAMATE	600MG	TABLET;ORAL	Prescription	No	AB	202284	ANI PHARMS
FELBAMATE	FELBAMATE	600MG	TABLET;ORAL	Prescription	No	AB	207093	TARO
FELBAMATE	FELBAMATE	600MG	TABLET;ORAL	Prescription	No	AB	208970	ZYDUS LIFESCIENCES
FELBATOL	FELBAMATE	600MG	TABLET;ORAL	Prescription	Yes	AB	020189	MYLAN SPECIALITY LP