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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201680
Company: AMNEAL PHARMS

Products on ANDA 201680

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 201680

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/13/2011	ORIG-1	Approval	Not Applicable		Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201680s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/24/2024	SUPPL-14	Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 201680

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

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